Recall of Datascope/Getinge/Maquet intra-aortic balloon pump is Class I

[Image from FDA]The FDA determined that the recall of the Datascope/Getinge/Maquet Cardiosave Hybrid and CardioSave Rescue devices is Class I, the most serious kind.

Datascope/Getinge/Maquet designed the CardioSave Hybrid and CardioSave Rescue intra-aortic balloon pumps (IABP) as cardiac assist devices for patients undergoing cardiac and non-cardiac surgery. They are used in adults who have acute coronary syndrome or complications of heart failure.

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