The FDA issued a notice determining another recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The … [Read more...] about Getinge’s Datascope has its second Class I recall in a month
Datascope
Getinge’s Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice determining a recall of Getinge subsidiary Datascope's Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company's Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in … [Read more...] about Getinge’s Datascope has another serious intra-aortic balloon pump recall
Getinge intra-aortic balloon pump recall is Class I
The FDA determined that Getinge's recall of its 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 … [Read more...] about Getinge intra-aortic balloon pump recall is Class I