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.
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 US Food and Drug Administration (FDA) has alerted users of Datascope Corp/MAQUET’s Cardiosave hybrid intra-aortic balloon pump (IABP) to a “design issue” that enables fluids to leak into the ...
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 ...
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 ...
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 ...