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FDA announces Class I recall of battery packs for intra-aortic balloon pumps due to risk of battery failure

The FDA has identified this as a Class I recall on Datascope/Getinge/Maquet for Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs due to the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting performance specifications being released to customers, which may cause the device to stop working when operated by battery only.

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The FDA has identified this as a Class I recall on Datascope/Getinge/Maquet for Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs due to the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting performance specifications being released to customers, which may cause the device to stop working when operated by battery only. 

Customers who have questions about this recall should contact their Datascope/Getinge/Maquet Sales Representative or, for technical questions, contact Customer Service (1-888-943-8872, option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

 

Read more:

https://www.fda.gov/medical-devices/medical-device-recalls/datascopegetingemaquet-recalls-cardiosave-hybridrescue-intra-aortic-balloon-pump-battery-packs-due

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