FDA: Class I recall of Getinge/Datascope/Maquet Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps

Editor's Note

The Food and Drug Administration, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious.

The IABPs are cardiac assist devices used in patients having cardiac and noncardiac surgery and to treat patients with acute coronary syndrome or heart failure.

The recall was initiated because of reports of fluid leaks. There has been one death and 71 complaints reported about this issue.

Distribution dates were March 6, 2012, to October 21, 2021.