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FDA announces Class I recall of Cardiosave intra-aortic balloon pumps (IABPs)

The FDA, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious.

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The FDA, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious.

Getinge/Datascope/Maquet is recalling these products due to complaints of fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy.
There has been one death and 71 complaints reported about this device issue.
 
Datascope/Getinge/Maquet plan to have representatives correct these issues by installing internal and external upgrades on every device.

The recall is the second related to the intra-aortic balloon pumps since Nov. 1, when the company issued a recall of 137 battery packs.

Read more:
https://www.fda.gov/

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