FDA announces Class 1 recall for ventilator system

Editor's Note

The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.  

According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation of the battery charger, which could trigger an alarm that makes the system inoperable. For patients, resulting risks include hypoxia, cognitive impairment, lethargy, changes in blood pressure, or even coma and death.

Baxter has corrected the issue and is offering replacement battery chargers, an no injuries or deaths have been reported. Patients may continue using the Lif2000 ventilator if it is functioning correctly, while others should contact the manufacturer per FDA instructions.