UCSF's renowned nursing school will graduate its final class of certified nurse-midwives next spring.

This article was published on Tuesday, September 3, 2024 in KFF Health News.

By Ronnie Cohen

One of California's two programs for training nurse-midwives has stopped admitting students while it revamps its curriculum to offer only doctoral degrees, a move that's drawn howls of protest from alumni, health policy experts, and faculty who accuse the University of California of putting profits above public health needs.

UC-San Francisco's renowned nursing school will graduate its final class of certified nurse-midwives next spring. Then the university will cancel its two-year master's program in nurse-midwifery, along with other nursing disciplines, in favor of a three-year doctor of nursing practice, or DNP, degree. The change will pause UCSF's nearly five decades-long training of nurse-midwives until at least 2025 and will more than double the cost to students.

State Assembly member Mia Bonta, who chairs the health committee, said she was "disheartened" to learn that UCSF was eliminating its master's nurse-midwifery program and feared the additional time and costs to get a doctorate would deter potential applicants. "Instead of adding hurdles, we need to be building and expanding a pipeline of culturally and racially concordant providers to support improved birth outcomes, especially for Black and Latina birthing people," she said in an email.

The switch to doctoral education is part of a national movement to require all advanced-practice registered nurses, including nurse-midwives and nurse practitioners, to earn doctoral degrees, Kristen Bole, a UCSF spokesperson, said in response to written questions. The doctoral training will feature additional classes in leadership and quality improvement.

But the movement, which dates to 2004, has not caught on the way the American Association of Colleges of Nursing envisioned when it called for doctorate-level education to be required for entry-level advanced nursing practice by 2015. That deadline came and went. Now, an acute need for maternal health practitioners has some universities moving in the other direction.

This year, Rutgers University reinstated the nurse-midwifery master's training it had eliminated in 2016. The University of Alabama-Birmingham also restarted its master's in nurse-midwifery program in 2022 after a 25-year hiatus. In addition, George Washington University in Washington, D.C., Loyola University in New Orleans, and the University of Nevada-Las Vagas added master's training in nurse-midwifery.

UCSF estimates tuition and fees will cost $152,000 for a three-year doctoral degree in midwifery, compared with $65,000 for a two-year master's. Studies show that 71% of nursing master's students and 74% of nursing doctoral students rely on student loans, and nurses with doctorates earn negligibly or no more than nurses with master's degrees.

Kim Q. Dau, who ran UCSF's nurse-midwifery program for a decade, resigned in June because she was uncomfortable with the elimination of the master's in favor of a doctoral requirement, she said, which is at odds with the state's workforce needs and unnecessary for clinical practice.

"They'll be equally prepared clinically but at more expense to the student and with a greater time investment," she said.

Nurse-midwives are registered nurses with graduate degrees in nurse-midwifery. Licensed in all 50 states, they work mostly in hospitals and can perform abortions and prescribe medications, though they are also trained in managing labor pain with showers, massage, and other natural means. Certified midwives, by contrast, study midwifery at the graduate level outside of nursing schools and are licensed only in some states. Certified professional midwives attend births outside of hospitals.

The California Nurse-Midwives Association also criticized UCSF's program change, which comes amid a national maternal mortality crisis, a serious shortage of obstetric providers, and a growing reliance on midwives. According to the 2022 "White House Blueprint for Addressing the Maternal Health Crisis" report, the U.S. has the highest maternal mortality rate of any developed nation and needs thousands more midwives and other women's health providers to bridge the swelling gap.

Ginger Breedlove, founder and CEO of Grow Midwives, a national consulting firm, likened UCSF's switch from master's to doctoral training to "an earthquake."

"Why are we delaying the entry of essential-care providers by making them go to an additional year of school, which adds nothing to their clinical preparedness or safety to serve the community?" asked Breedlove, a past president of the American College of Nurse-Midwives. "Why they have chosen this during one of the worst workforce shortages combined with the worst maternal health crisis we have had in 50 years is beyond my imagination."

A 2020 report published in Nursing Outlook failed to find that advanced-practice registered nurses with doctorates were more clinically proficient than those with master's degrees. "Unfortunately, to date, the data are sparse," it concluded.

The American College of Nurse-Midwives also denounced the doctoral requirement, as have trade associations for neonatal nurse practitioners and neonatal nurses, citing "the lack of scientific evidence that … doctoral-level education is beneficial to patients, practitioners, or society."

There is no evidence that doctoral-level nurse-midwives will provide better care, Breedlove said.

"This is profit over purpose," she added.

Bole disputed Breedlove's accusation of a profit motive. Asked for reasons for the change, she offered broad statements: "The decision to upgrade our program was made to ensure that our graduates are prepared for the challenges they will face in the evolving health care landscape."

Like Breedlove, Liz Donnelly, vice chair of the health policy committee for the California Nurse-Midwives Association, worries that UCSF's switch to a doctoral degree will exacerbate the twin crises of maternal mortality and a shrinking obstetrics workforce across California and the nation.

On average, 10 to 12 nurse-midwives graduated from the UCSF master's program each year over the past decade, Bole said. California's remaining master's program in nurse-midwifery is at California State University in Fullerton, south of Los Angeles, and it graduated eight nurse-midwives last year and 11 this year.

More than half of rural counties in the U.S. lacked obstetric care in 2018, according to a Government Accountability Office report.

In some parts of California, expectant mothers must drive two hours for care, said Bethany Sasaki, who runs Midtown Nurse Midwives, a Sacramento birth center. It has had to stop accepting new clients because it cannot find midwives.

Donnelly predicted the closure of UCSF's midwifery program will significantly reduce the number of nurse-midwives entering the workforce and will inhibit people with fewer resources from attending the program. "Specifically, I think it's going to reduce folks of color, people from rural communities, people from poor communities," she said.

UCSF's change will also likely undercut efforts to train providers from diverse backgrounds.

Natasha, a 37-year-old Afro-Puerto Rican mother of two, has spent a decade preparing to train as a nurse-midwife so she could help women like herself through pregnancy and childbirth. She asked to be identified only by her first name out of fear of reducing her chances of graduate school admission.

The UCSF program's pause, plus the added time and expense to get a doctoral degree, has muddied her career path.

"The master's was just the perfect program," said Natasha, who lives in the Bay Area and cannot travel to the other end of the state to attend CSU-Fullerton. "I'm frustrated, and I feel deflated. I now have to find another career path."

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

The unusual step comes as CMS is under the gun to curb unauthorized enrollment and switching of ACA plans by rogue agents.

This article was published on Thursday, August 22, 2024 in KFF Health News.

By Julie Appleby

Federal regulators have blocked two private sector enrollment websites from accessing consumer information through the federal Obamacare marketplace, citing "anomalous activity."

The unusual step comes as the Centers for Medicare & Medicaid Services is under the gun to curb unauthorized enrollment and switching of Affordable Care Act plans by rogue agents. The agency received more than 200,000 complaints in the first six months of the year about such actions.

CMS said in a written statement that it had suspended the two sites — Benefitalign and Inshura — "while the anomalous activity is researched to ensure the EDE partners are in compliance with CMS data standards." EDE stands for "enhanced direct enrollment" and refers to websites approved to integrate with healthcare.gov.

In a separate development, the two websites, which insurance brokers use instead of the federal healthcare.gov site to enroll clients in Affordable Care Act plans, are mentioned in an ongoing civil lawsuit filed by attorneys representing consumers and agents who claim they've been harmed by enrollment schemes.

CMS posted on Aug. 9 an updated list of websites approved to integrate with the federal Obamacare marketplace that no longer included Benefitalign and Inshura. As a result, insurance agents can't use the websites to enroll customers in or make changes to their Obamacare plans.

Private sector enrollment sites were first allowed to integrate with healthcare.gov data under the Trump administration. About a dozen such sites are now approved to connect with the federal system.

Thwarting enrollment schemes and rogue insurance agents without making it too difficult for consumers and legitimate agents to enroll in health plans has become a political problem for the Biden administration. President Joe Biden has claimed record-breaking enrollment under the ACA as one of his administration's major accomplishments.

In recent weeks, lawmakers have called on CMS to do more and introduced legislation to increase penalties for agents who enroll people in plans without authorization. The large number of complaints from victims of the schemes have caught the attention of House Republicans, who on June 28 requested investigations by the Government Accountability Office and the Office of Inspector General at the Department of Health and Human Services.

KFF Health News began reporting on ACA enrollment schemes early this year.

CMS has since taken actions to short-circuit unscrupulous agents and call centers.

Until last month, agents using the approved private sector enrollment sites could access consumer information via healthcare.gov with only a name, birth date, and state of residence. CMS now requires three-way calls among agents, consumers, and the healthcare.gov helpline when agents new to a policy try to make a change. Many legitimate insurance agents are urging an additional fix used widely by state Obamacare enrollment systems: requiring two-factor authentication before consumer information can be accessed or changed by agents.

Meanwhile, the move to suspend the two enrollment websites baffled the companies, said Catherine Riedel, a spokesperson for TrueCoverage, an insurance call center that also does business as Inshura. TrueCoverage and Benefitalign are subsidiaries of Speridian Global Holdings of California.

"We don't know what they want us to do differently," she said.

The websites, she said, are cooperating with CMS, and they conducted an internal review that found no security issues. Very few details, other than "it is related to a potential technical anomaly reported by an outside party" were given, Riedel wrote, and the firms have not been provided "any specific, actionable information related to the alleged anomaly."

Both firms are mentioned in the lawsuit first filed in April in the U.S. District Court for the Southern District of Florida. The suit alleges that people and organizations engaged in misleading advertising, or made changes to ACA policies, without the express permission of consumers — all with a goal of racking up commissions.

Late on Aug. 16, that case was amended to add allegations and defendants, including Benefitalign. The other enrollment website, Inshura, is not listed as a defendant, although it is run by TrueCoverage, which is.

Riedel said TrueCoverage disputes the lawsuit's claims.

The case "is founded on misinformation and technical naivety that seems to have been connected to create a sensational and false narrative," she said.

The Aug. 16 filing alleges that TrueCoverage or Speridian Technologies, another subsidiary of Speridian Global Holdings, used the Benefitalign or Inshura websites to access U.S. consumers' personal information, then sent it to marketers in India and Pakistan. The allegation, if true, would violate agreements the private sector websites made with the federal government to gain approval to operate, the suit contends.

Riedel said there is no evidence to support the allegations and that it is technically impossible to move "bulk amounts of consumer data" from the Obamacare marketplace.

"Like many technology companies, some of TrueCoverage's marketing efforts have been based in India. However, as part of that marketing work, TrueCoverage did not move any customer data out of the EDE platform," she said.

The 185-page amended complaint added as a defendant Bain Capital Insurance Fund, part of one of the world's leading private investment companies, saying it "aided and abetted" Florida-based Enhance Health, which describes itself as a large broker of ACA plans. Bain helped launch Enhance with a $150 million investment in 2021 and appointed its CEO.

After initially planning to market Medicare Advantage plans, the lawsuit says, Enhance Health and Bain decided to shift to ACA plans, which were seen as more profitable. The suit alleges Enhance Health participated in unauthorized agent changes or switching of ACA policies.

Bain knew "what was going on" at Enhance "and ultimately supported it," the lawsuit says, noting that Bain executives sat on Enhance's board, controlled the hiring of executives, and were often at its Sunrise, Florida, offices. The firm hoped to sell the company once it showed how profitable it could be, the suit alleges.

In a written statement, Enhance Health said that "upholding the highest standards of compliance and controls is a core focus in all aspects of our operation and we will vigorously defend against these baseless claims."

Bain Capital Insurance did not reply to a request for comment.

The additional allegations expand on the initial April filing, which outlined a complex web of activities aimed at capitalizing changes to the ACA under Biden that resulted in broader availability of zero-premium plans for lower-income applicants. In some cases, consumers were lured to call centers through misleading ads touting nonexistent cash cards. Some call centers or agents filed duplicate coverage for the same individuals, without consumer permission, or split family members among multiple policies, the suit alleges.

Because the customers don't pay monthly premiums for the plans, they may not notice they've been enrolled until they try to obtain care.

Some consumers whose plans were switched lost access to their doctors or medications. Some face tax consequences if they were enrolled in duplicative coverage or in subsidized plans for which they did not qualify.

One victim added to the case, Paula Langley of Texas, initially responded to an advertisement promising a cash card. She called the number advertised and was enrolled in ACA coverage in February 2023 but never received the promised incentive, according to the lawsuit.

She and her husband began receiving multiple insurance cards from different insurers, the suit says. She would show up for a doctor's visit or to pick up a prescription only to find her coverage had been canceled, leaving her with unpaid medical bills.

All in all, she was switched among plans and agents at least 22 times in just over a year, the lawsuit alleges.

Attorneys Jason Kellogg of Miami and Jason Doss of Atlanta said they amended the lawsuit based on dozens of interviews with former employees of the named firms. They're seeking class-action status on behalf of affected consumers and agents who have lost business to the unauthorized plan-switching, and the suit alleges violations of the federal Racketeer Influenced and Corrupt Organizations — or RICO — Act.

"The scheme is bad enough because it's so large," Kellogg said. "But it's much worse given that it preys upon Americans who are at the lowest levels of the income scale, who may be desperate, are most vulnerable."

Julie Appleby: jappleby@kff.org, @Julie_appleby

However, whether new CON laws improve care or reduce costs is questionable.

This article was published on Monday, August 19, 2024 in KFF Health News.

By Andy Miller and Sam Whitehead

ATLANTA — At the shuttered Atlanta Medical Center, a "Stronger Together" mural sends a hopeful message near a summer spray of hydrangeas. The campus was mostly quiet on a recent weekend, since AMC closed almost two years ago. A lone security vehicle sat behind a chain-link fence, and pedestrians passed by without even a glance.

In the town of Cuthbert, some 160 miles away, the Southwest Georgia Regional Medical Center also remains shut after closing four years ago, another Southern hospital casualty in a region dotted with them. Even a smaller facility replacing the former Cuthbert hospital "would be tremendous for the county," said Steve Whatley, chair of the Randolph County Hospital Authority.

The two hospitals — one inner-city, the other rural — faced some of the same financial pressures, including not having enough patients with private insurance.

This year, they also shared the attention of some of Georgia's most powerful lawmakers. Legislation signed in April by Gov. Brian Kemp, a Republican, included a provision pushed by U.S. Sen. Jon Ossoff, a Democrat.

The law amends the state's "certificate of need" system, which allows existing hospitals and other health facilities to block would-be competitors' plans to expand by arguing there's insufficient need for their services.

Certificate of need laws exist in 35 states and Washington D.C., according to the National Conference of State Legislatures. The hospital industry, especially nonprofit facilities, generally support the rules, and have argued they reduce health care costs and preserve access to quality medical services. Under CON requirements, health providers must obtain approval from the state before offering some new services or before building or expanding facilities.

Whether the laws improve care or reduce costs is questionable, researchers have found, and critics say more competition would decrease spending by insurers and consumers. In 2018, the Trump administration issued a report recommending that states repeal or revise their certificate of need requirements, arguing they increase health care costs.

"The evidence is pretty darn overwhelming that CON laws don't achieve the initially stated goals of increasing access, lowering costs, and improving quality," said Matthew Mitchell, a senior research fellow at West Virginia University.

Dan Sullivan, a Georgia-based consultant who often helps hospitals and other medical providers in their effort to preserve the laws, said that by limiting the number of providers offering very specialized health services, such as organ transplants, states can better maintain high quality of care.

Certificate of need laws can reduce fraud, Sullivan said. Florida repealed its certificate of need requirements for hospitals and many other health providers following the Trump administration's recommendation. Fraud accelerated in the state after regulations were phased out, he said.

"At least when you file a CON, there's at least a minimum of investigation," Sullivan said.

He argued another benefit of the laws is that they frequently mandate a baseline level of charity care.

Other Southern states recently peeled back their certificate of need laws. Tennessee's legislature passed a bill this year exempting more medical providers from needing to apply for a certificate. North Carolina rolled back some restrictions in an overhaul that paved the way for Medicaid expansion last year. South Carolina made a significant change to its rules last year.

This year, Republicans in Georgia's legislature attempted to repeal the state's certificate of need rules. The effort fell short in the face of fervent hospital opposition.

The narrower legislation that Kemp signed would instead ease the rules for building rural hospitals and exempts a potential new hospital that would partner with Morehouse School of Medicine, one of the country's few historically Black medical schools.

That could potentially fill much of the gap left by Atlanta Medical Center's closing.

Hospital industry officials said Morehouse would probably need a well-heeled partner, and Atrium Health, part of Charlotte, North Carolina-based Advocate Health, may be a logical match. The growth-oriented nonprofit health system has partnered with Morehouse Healthcare to run a clinic in East Point, south of Atlanta, and has a growing presence in the state. Both Morehouse and Atrium declined to discuss a potential hospital partnership with KFF Health News.

The shuttered AMC main campus, meanwhile, is ensnared in a moratorium the city imposed on redeveloping the site — a response to the jolting decision by its owner, Wellstar Health System, to close the hospital.

In 2022, Mayor Andre Dickens issued an executive order temporarily halting any new development on the site. He has criticized the "unusually abrupt closure of one of Atlanta's most important medical centers."

Atlanta's city council extended the ban another 120 days in June.

A new inner-city hospital "would be a heavy lift financially," said Josh Berlin, CEO of rule of three, an Atlanta-based health care consulting firm. That's because it would draw largely from the area's high level of uninsured and Medicaid patients. Georgia is one of 10 states that have not fully expanded Medicaid, and thus has a high rate of uninsured patients.

"You've got a community that is struggling to find care in the wake of the Atlanta Medical Center closure," he said.

Grady Memorial Hospital and other Atlanta facilities have seen a bump in patient volume since the closure of AMC. Grady is regularly deemed "dangerously overcrowded" in one state dashboard.

The need to handle additional patients has sped up expansion plans for Grady, including adding more than 150 beds, said its chief strategy officer, Shannon Sale. "We knew that was going to be needed over time. The Atlanta Medical Center closure sped up that process," she said.

In southwestern Georgia, plans are more modest.

Community leaders, including Whatley, are awaiting the results of a feasibility study that is expected to propose a downsized "rural emergency hospital," a new federal designation that directs extra funding to eligible facilities.

The program guarantees hospitals in rural communities extra Medicare payments and an additional payment of about $3.2 million a year if they close costly inpatient services and offer only emergency and outpatient care.

Ossoff won almost $12 million in three different appropriations bills to support a rural emergency hospital in Cuthbert. He said he met with state leaders to secure the provision in the Georgia certificate of need bill that would allow it to reopen. Southwest Georgia Regional Medical Center would also have to get an exemption from federal officials to qualify for a rural emergency hospital because of its closing date.

"This is a very challenging thing to do, and we've still got significant hurdles to clear," Ossoff told KFF Health News.

Even if it reopens, the Cuthbert facility will face the same pressures that led to its shuttering in the first place — what Ossoff called "failures of state policy." At the time, he cited Georgia's decision not to fully expand Medicaid in the wake of the closure.

Brenda Clark, who works in a wellness center across the street from the closed Cuthbert hospital, said some locals are skeptical about the facility reopening.

"It's much needed. People are hoping and praying we get it back," she said. But "there are some people who say, ‘We'll believe it when we see it.'"

Andy Miller: @gahealthnews

Sam Whitehead: swhitehead@kff.org

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals.

This article was published on Thursday, August 15, 2024 in KFF Health News.

By David Hilzenrath

n 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said.

"Use of this device may cause serious injuries or death," an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, "Abbott is not removing product from commercial distribution." Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only "removals," in which the device is removed from where it is used or sold, but also "corrections," which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

"It's very oxymoronic," said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. "A recall makes it sound like it's recalled. But that is not actually what it means."

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as "non-recalls." And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don't remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

"When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device," FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, "removal" doesn't necessarily mean removing them from patients' bodies. "When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place," the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use "because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm's recall strategy was appropriate and adequate," Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective "based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation," a condition in which blood flows backward through the heart's mitral valve. The condition can lead to heart failure and death.

"With MitraClip, we're addressing the needs of people with MR who often have no other options," company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, "So hard to imagine these are effective actions in protecting patients."

In 2021, for Medtronic's StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it's meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in "life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death."

The FDA website explained what Medtronic was doing about it.

"The recalling firm will provide a warning and instructional placard to be applied to impacted systems," the website said. "Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring," it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company's primary concern, and certain issues "can be safely and effectively remedied with a correction on site."

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

"But, I mean, then you could ask, ‘Well, why don't they just disable the view [of the brain] that's bugged?'" Everson said. "Why would they give you the option of looking at an inaccurate one?"

"That's kind of a strange solution," he said.

The FDA lists the 2021 recall as still open, explaining "not all products have been corrected or removed."

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they "had almost no speech for two days," according to a Medtronic report. In the report, Medtronic said there was "insufficient information to determine the relationship of the software to the reported issue."

In a February 2024 case, after brain surgery, an MRI found that the operation "missed the tumor" and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

"Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed," Medtronic's Winkels told KFF Health News in a July email. "While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions."

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of "destruction of the impeller blades," which could cause "low flow" and "embolization of the fractured impeller material," an entry on the FDA website said.

"Clinicians are cautioned to position the Impella system carefully in patients," the FDA website said, among other instructions.

The updated instructions "provide technical guidance to mitigate the risk of rare complications," Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events "related to product design or manufacturing," Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that "alternative treatments are limited" and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to "transition away from these devices and seek alternatives, if possible."

"These recommendations are based on our continued concerns" that the manufacturer "has not sufficiently addressed the problems and risks with these recalled devices."

Getinge sent KFF Health News written answers from Elin Frostehav, the company's president of Acute Care Therapies.

"There is no question that we would have liked to have solved these issues in full much earlier," she said.

As a result of the FDA's May action, the company "immediately paused proactive marketing" of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

"We are working with the agency to finalize remediation and product update solutions," Frostehav said.

'Known Possible Complications'

Abbott's MitraClip system includes tiny clips implanted in the heart's mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which "the user was unable to separate the implantable Clip from the delivery system."

In a news release at the time, Abbott said it had "received a small number of reports" in which that happened.

Those cases "resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem," the FDA said in a 2016 notice. "There was one patient death in these cases as a result of severe comorbidities following surgery."

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn't separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system "had to be cut down in order to detach the clip."

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient "coded" the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed "case-specific circumstances."

"Cardiac arrest, hemorrhage and death are listed" in the device instructions "as known possible complications associated with mitraclip procedures," the company said. "There is no indication of a product issue with respect to manufacture, design or labeling."

The third MitraClip recall, initiated in September 2022, cited an "increase in clip locking malfunctions."

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip "remains within the anticipated risk levels," the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device's instructions. But the 2022 recall identified a contributing factor: the way the device was made.

"Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components," the company said in a 2022 letter to customers.

"Abbott is working on producing new lots with updated manufacturing processing and raw material," the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

"There is no evidence that death was related to the device but it was likely related to the procedure," Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and "not all products have been corrected or removed."

KFF Health News data editor Holly K. Hacker contributed to this report.

If you've had an experience with a medical device and would like to tell KFF Health News about it, click here to contact our reporting team.

David Hilzenrath: dhilzenrath@kff.org, @DavidHilzenrath