Datascope/Getinge expands recall of certain IABPs for risk of unexpected shutdown after PCBA communication loss

Editor's Note

The Food and Drug Administration (FDA) on March 31 identified the recall by Datascope/Getinge of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) for risk of unexpected shutdown after PCBA communication loss as Class I, the most serious.

On March 17, the FDA also identified Datascope/Getinge’s recall of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because the coiled cable connecting the display and base on some units may fail as Class I.

The company has reported 42 complaints about this issue, and there are no reports of injuries or deaths.

Distribution dates were March 6, 2012, to January 13, 2023.