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 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, ...

Please provide your email address to receive an email when new articles are posted on . Datascope/Maquet/Getinge intra-aortic balloon pumps recalled due to risk for unexpected shutdown. The FDA has ...

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 ...

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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Compared with standard medical care, early use of a temporary intra-aortic balloon pump (IABP) to support heart function in patients who were critically ill with cardiogenic shock caused by heart ...