FDA: Class I recall of Cardiosave Hybrid and Rescue IABPs

Editor's Note

The Food & Drug Administration on November 2 identified the recall by Maquet Datascope Corp/Getinge Group’s Cardiosave Hybrid and Cardiosave Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious.

The recall was initiated because of the potential for the autofill process to malfunction or fail during use at altitudes above 3,200 feet. Failure may result in interruption or cessation of therapy on the first maintenance autofill or the inability to start therapy.

Maquet/Getting is developing a software correction to address the issue and anticipates installing the software, starting February 2019.