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FDA announces Class I recall of Cardiosave intra-aortic balloon pumps (IABPs)

The FDA, 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. Getinge/Datascope/Maquet is recalling these products due to complaints of fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy.There has…

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