Getinge subsidiary Datascope has recalled thousands of Intra-Aortic Balloon Pumps in 2023, and in the latest notice, the FDA labeled the issue as Class I because of unexpected shutdowns. On Aug. 10, ...
Getinge’s intra-aortic balloon pumps seem to have lost their rhythm: Already this year, the devices have been the target of a handful of FDA Class I recalls in the U.S. and a CE mark suspension in ...
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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IABP systems are typically inserted within the multidisciplinary environment that is the cardiac catheterization laboratory. The specific role of the physiologist during IABP insertion is to ensure ...
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