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Getinge

Getinge’s Atrium Medical has a Class I recall over covered stents

June 2, 2022 By Danielle Kirsh

Atrium Medical logo

The FDA today determined that Atrium Medical's recall of some of its iCast covered stents is Class I, the most serious kind. Hudson, N.H.–based Atrium Medical — a subsidiary of Swedish medtech giant Getinge — is recalling certain iCast covered stent systems due to complaints of separation of the balloon or catheter hub from the delivery system … [Read more...] about Getinge’s Atrium Medical has a Class I recall over covered stents

Filed Under: Catheters, Stents Tagged With: Atrium Medical, Getinge

Getinge intra-aortic balloon pump recall is Class I

December 17, 2021 By Sean Whooley

Datascope_Getinge_Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump

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 … [Read more...] about Getinge intra-aortic balloon pump recall is Class I

Filed Under: Balloons Tagged With: Datascope, fda, Getinge, Maquet

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