More than 250 devices have been recalled so far.
Baxter Healthcare has issued a Class 1 recall—the most serious type of recall—for Volara systems issued between May 28, 2020 to April 19, 2022. The in-line ventilator adaptor of the OPTIMUS Handset 2 and OPTIMUS OLE AC Patient Circuit Kit may prevent home-use patients from getting enough oxygen.
Some risks affected patients may experience include choking on mucus or other airway secretions, infection in the lungs that can prevent oxygen from getting to the blood, brain injury caused by lack of oxygen to the brain, and death, according to the FDA.
The Volara system is used for clearing mucus out of airways, expanding the lungs, and to treat or prevent a partial lung collapse. Its in-line ventilator adaptor allows it to be used with ventilators in home care settings.
This recall applies to Volara systems with in-line ventilator adaptors or Volara patient circuit kits, with product model numbers PVLIHCBA, M08594, and M08594A. As of late June, 268 devices had been recalled in the US, one reported complaint, one reported injury, and two deaths associated with them, according to the FDA.
Hillrom, Baxter Healthcare’s subsidiary company, issued an Urgent Medical Device Correction letter to customers on April 26, which listed potential actions they may take, which includes monitoring for signs of respiratory distress and contacting their Clinical Support team at 800-397-9071.
Jasmyne Ray is the revenue cycle editor at HealthLeaders.