The FDA issued a notice labeling another recall of Getinge subsidiary Datascope’s Cardiosave pump as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs). Both devices were subject to two separate Class I recalls in March. The company also initiated a Class I […]
Maquet
Getinge intra-aortic balloon pump recall is Class I
The FDA determined that Getinge’s recall of its Cardiosave Hybrid and CardioSave Rescue devices is Class I, the most serious kind. Datascope/Getinge/Maquet designed the CardioSave Hybrid and CardioSave Rescue intra-aortic balloon pumps (IABP) as cardiac assist devices for patients undergoing cardiac and non-cardiac surgery. They are used in adults who have acute coronary syndrome or […]
Getinge recalls cardiac pumps following reports of 5 deaths
Getinge (STO:GETI-B) is recalling four models of Maquet/Datascope intra-aortic balloon pumps (IABP) due to reports of faulty batteries. Five deaths have been reported since March 2016. The IABP batteries failed to hold a charge, stopped unexpectedly, or had a shortened run-time, which may have caused the device to stop working when being operated by battery […]