The US Food and Drug Administration (FDA) continues to receive reports of device failures associated with Maquet/Datascope Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS100/CS100i intra-aortic ...

Getinge is recalling numerous Maquet/Datascope intra-aortic balloon pumps (IABPs) due to potential battery failure during use that can lead to unexpected stopping and shortened run times.

(UPDATED) The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been placed under recall by the manufacturer (Getinge/Datascope/Maquet) following reports of fluid leaks, ...

Maquet/Datascope intra-aortic balloon pumps (IABPs) may be at risk of shutting down while running on batteries, failure of their batteries to charge, or premature battery depletion, the US Food and ...

The U.S. FDA reported yet another recall of intra-aortic balloon pumps made by Datascope Corp., an unfortunate development for patients in need of these devices that are still on the FDA’s list of ...

The warning covers Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets ...

Getinge AB reported that intraortic balloon pumps (IABPs) manufactured by its Datascope subsidiary are in short supply following a recall of some of these devices in 2019. Getinge said manufacturing ...

The FDA placed some balloon pumps on its medical device shortage list Dec. 2, which the agency said was because of increased demand and shortage of some of the product’s components. There is a ...

The FDA on Jan. 25 announced a class 1 recall of Datascope/Getinge’s Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump after one death and four serious injuries were reported. A class 1 recall ...

Please provide your email address to receive an email when new articles are posted on . The FDA announced that Maquet Datascope Corp. has recalled a hybrid intra-aortic balloon pump due to a design ...

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 ...

Getinge Group subsidiary Datascope failed to adequately conduct device design validation, establish procedures for corrective and preventive actions (CAPAs) and evaluate and select potential suppliers ...