August 11, 2023

FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs

Editor's Note

The Food and Drug Administration (FDA), on August 10, identified the recall by Datascope/Maquet/Getinge of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious.

The recall was initiated because the pumps may shut down unexpectedly due to electrical failures in the Power Management Board or Solenoid Board (Power Source Path).

The company reports 26 complaints, no injuries, and no deaths associated with this issue.

Distribution dates were March 6, 2012, to May 19, 2023.


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