Getinge is recalling 4,338 intra-aortic balloon pumps after discovering fluid leaks that can lead to unexpected shutdowns or the inability to initiate therapy, the FDA said Dec. 16. The agency has ...
Just a week after Getinge temporarily lost CE mark clearance in Europe for its Cardiosave intra-aortic balloon pumps, the FDA has handed down a Class I recall rating to the devices—the second such ...
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