Reported Jan 16, 2013 · Terminated
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It…
Maquet Cardiovascular, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
- Lot codes and dates
- 510K K112372 Device Listing Number D132687 US Customer IABPs CA202159K1 CA202167K1 CA203492L1 CA203494L1 International Customer IABPsInternational Company Owned IABPs CA204327L1 CA202150K1 CA203506L1 CA204324L1 CA204326L1 CA202163K1 CA202169K!
CA203486L1CA202155K1CA202161K1CA203487L1CA203490L1CA203507L1CA204330L1CA204328L1CA203505L1
CA203497L1CA203498L1CA203496L1CA203503L1CA203488L1CA203493L1CA203508L1CA204337L1CA203502L1
- 510K K112372 Device Listing Number D132687 US Customer IABPs CA202159K1 CA202167K1 CA203492L1 CA203494L1 International Customer IABPs
- Amount recalled
- 29 units (total)
Where it was sold
Why it was recalled
In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
This product could cause temporary or reversible health problems — stop using it.
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