The U.S. Court of Appeals for the Federal Circuit has brought back a patent infringement case between Getinge’s Maquet and Johnson & Johnson’s Abiomed. This lawsuit dates back to 2016, when heart pump maker Abiomed, now a Johnson & Johnson MedTech unit, sued Getinge’s Maquet for a judgment of non-infringement of a trio of patents. Counter-suits later […]
Maquet
FDA warns of ‘continued safety and quality concerns’ in Getinge recalls
The FDA today sent a letter to health care providers and facilities expressing “continued safety and quality concerns” about Getinge/Maquet cardiovascular medical devices. 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 continues to receive medical device reports (MDR) related to […]
Getinge subsidiary Datascope has another serious intra-aortic balloon pump recall
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 […]
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 […]
