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 ...

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 ...

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 ...

More than 2,000 heart balloon pumps are part of a Class I recall issued by the FDA. The two models being recalled — Cardiosave Hybrid and Rescue pumps made by Datascope, a subsidiary of Getinge — have ...

The U.S. Food and Drug Administration (FDA) classified the recall of Getinge's (OTCPK:GNGBF) (OTCPK:GNGBY) heart devices as the agency's Class 1 recall, the most serious type of recall as their use ...