Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps
On January 25, 2023, the U.S. Food and Drug Administration (FDA) announced that Datascope is recalling its Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Rescue IABPs. Datascope had distributed 4,454 of the devices since March 6, 2012. At the time of the recall, the company had reported 134 complaints, including 12 device … [Read more...] about Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps
Cardiac Devices Due to Battery Issues
UNITED STATES – The medical device manufacturer Maquet is recalling thousands of cardiac devices called intra-aortic balloon pumps (IABPs) due to battery issues that could be life-threatening to patients. The U.S. Food and Drug Administration announced the recall in May 2019 because of concerns that the devices could lose charge and … [Read more...] about Cardiac Devices Due to Battery Issues
Intra-Aortic Balloon Pumps Recall
A voluntary recall is in effect for certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corporation, for a potential electrical test failure code. This field correction applies as well, to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP, according to the U.S. Food and Drug Administration (FDA). … [Read more...] about Intra-Aortic Balloon Pumps Recall
