Dive Brief:

• The Food and Drug Administration has categorized a recall of Baxter’s Volara ventilator system as a Class I event after receiving reports of two deaths associated with the device.
• Baxter initiated a recall of 259 Volara patient circuit kits, plus nine other Volara units, in the U.S. after discovering the devices may stop home-use patients from receiving enough oxygen from their ventilators. The issue is linked to one complaint, one injury and two deaths.
• The affected products were brought to market by Hillrom, the medtech company that Baxter acquired last year in a $10.5 billion deal to expand its digital-health and connected-care offerings.

Dive Insight:

Hillrom developed Volara to enable respiratory patients to receive oscillation and lung-expansion therapy at home. As well as expanding the lungs, the system is designed to help clear mucus from the airways and treat or prevent partially collapsed lungs. An in-line ventilator adaptor component lets the system be used in home-care settings.

Patients using the in-line adaptor may not receive sufficient oxygen, Baxter disclosed at the start of the month. The company noted one report of oxygen desaturation while using Volara in line with a ventilator in a home-care environment. Weeks later, the FDA’s notice referenced one complaint, one injury and two deaths.

The recall was a Class I event, the FDA said, indicating that the 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.  

“The risk of serious injury or death is more significant in home-care 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. 

After discovering the issue, Baxter told customers to continue to use Volara therapy as prescribed but to take some precautions to mitigate the risks. 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. 

To ensure correct usage of the device, Baxter’s Hillrom plans to update the device’s instruction manual and arrange a home visit with a clinical patient trainer to provide more training to customers.