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Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns

Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because it may shutdown unexpectedly due to failures in the printed circuit board assembly (PCBA) in the charging path. If this occurs, the device may lose the ability to charge batteries in one or both battery bays/slots due to electrical surge damage in the Power Management Board Charging Path Circuit.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Questions?

Customers with questions about this recall should contact their Datascope/Maquet/Getinge representative or call Datascope/Maquet/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time).