FDA Upgrades Seriousness of Baxter Volara Recall

BIRMINGHAM, Ala. (June 24, 2022)—The United States Food and Drug Administration (FDA) announced this week that it has upgraded the recall of the Baxter Volara system to a Class I event, the most serious category. Baxter Healthcare Corporation and its subsidiary company Hillrom issued the recall in late April following two reported deaths and one injury.

The Volara system enables respiratory patients to receive lung oscillation and lung-expansion therapy in the home. The system includes an adaptor so it can be used as a ventilator; however, ventilator patients using the adaptor may experience an overexpansion of the lungs and subsequent drop in oxygen levels, Baxter disclosed. The recall affects just under 270 devices.

The FDA indicated that using the Volara in line with a ventilator carries the risk of serious injuries or death and may cause patients to choke on mucus, have respiratory failures, suffer brain injuries from lack of oxygen and die, resulting in the Class I classification.

“The risk of serious injury or death is more significant in homecare settings if the caregivers are not trained properly, the device is not connected properly or if the caregiver is not prepared to address any issues that may arise caused by use of this device,” the FDA wrote in its recall notice.

Despite the risks, Baxter told customers to continue to use Volara therapy as prescribed. However, customers should ensure their doctor prescribes the suction unit alongside the Volara system and users should be monitored for signs of respiratory distress such as increased breathing rate, wheezing and any decrease in oxygen saturation levels. 

Baxter plans to update the device’s instruction manual and arrange a home visit with a clinical patient trainer to provide more training to customers.