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FDASeptember 20, 2018device

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

What to do

FDA enforcement status: Ongoing

Brands named

maquet datascope corp cardiac assist divisionmaquetmaquet datascope

UPCs

10607567108407

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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