Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump Recalled Due to Reports of Fluid Leaks

U.S. Food and Drug Administration sent this bulletin at 12/16/2021 09:20 AM EST

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FDA - Center for Devices and Radiological Health

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Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks

Getinge is recalling the Datascope/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump due to complaints of fluid leaks.

Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy.

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.

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Questions?

If you have questions about this recall, contact your Getinge/Datascope/Maquet Sales Representative, or call Customer Service at 1-888-943-8872, and press option 2, Monday through Friday, between 8:00 a.m. and 6:00 p.m. EST.