FDA Classifies Cardiosave IABP Recall as Class I

Patrice Wendling

December 16, 2021

Getinge is recalling its Datascope/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because of reports of fluid leaks.

There has been one death and 71 complaints reported about the issue to date, according to the US Food and Drug Administration (FDA), which has identified this as a class I recall, the most serious type.

"Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy," the FDA said in a statement posted today.

The IABP devices are used with patients undergoing cardiac and noncardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure, the agency notes.

The recall affects 4338 devices that were distributed in the United States between March 6 and October 21, 2021.

Getinge/Datascope/Maquet sent an Urgent Medical Device Correction Letter regarding the issue to customers on November 15. It plans to correct all IABP devices in the field to include various internal and external component upgrades that will be made available in an Ingress Prevention Upgrade Kit and will be installed by a Getinge/Datascope service representative, the notice states.

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