FDA Provides Update on Vyaire Medical’s Ventilator Recall

The FDA has issued an update on Vyaire Medical’s Dec. 23 recall of its bellavista 1000 and 1000e series ventilators, deeming it a Class 1 recall because of the risk of serious injury or death.

The ventilators are used to assist patient breathing by delivering air, or air with extra oxygen, into the airways or lungs. Problems with the software configuration may cause the ventilators to malfunction or stop working, the agency said. The 2,605 affected products were distributed from Jan. 26, 2017, to Dec. 23, 2021.

Ventilators with software version 6.0.1600.0 or higher installed can have a conflict in memory between software tasks when the data communication port is set to “HL7,” which produces a technical failure alarm, causing the device to malfunction or shut down. There have been 18 complaints and seven reported injuries, but no deaths, the agency said.