FDA announces serious device recall
The Food and Drug Administration today a Class 1 recall of battery packs for an intra-aortic balloon pump used with patients undergoing surgery and to treat adults with acute coronary syndrome or heart failure complications. Datascope/Getinge/Maquet is recalling 137 substandard battery packs for the CardioSave Hybrid/Rescue Intra-Aortic Balloon Pump, which may cause the cardiac assist device to stop working when operated by battery only. Customers should examine their inventory immediately and replace any affected battery packs with an unaffected battery, the company said.
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