FDAMay 3, 2018device
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
What to do
FDA enforcement status: Ongoing
Brands named
maquet datascope corp cardiac assist divisionmaquetmaquet datascope
UPCs
099800080083099800080075
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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