Tag: IABP
FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…
FDA: Class I recall of Datascope/Getinge Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA) on January 25 identified the recall by Datascope/Gettinge of its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the risk that blood may enter the pump through a damaged balloon…
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