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FDADecember 16, 2015device

Cardiosave Hybrid and rescue IABP

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

The hazard

Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

What to do

FDA enforcement status: Terminated

Brands named

maquet datascope corp cardiac assist divisionmaquetmaquet datascope

UPCs

099800080053099800080083

Recall history

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

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