The Food and Drug Administration (FDA), on October 29, identified the recall by Datascope/Getinge/Maquet of its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs as Class I, the most serious.
The recall was initiated because of the risk of the battery failing and having a shortened run time, which may cause the balloon pump to stop working when operated by battery only.
Intra-aortic balloon pumps are cardiac assist devices used in patients undergoing cardiac and non-cardiac surgery and to treat heart failure patients.
The company has received six complaints and no reports of injuries or deaths related to this issue.
Distribution dates were September 23, 2017, to August 17, 2021.Read More >>