Reported Mar 4, 2015 · Terminated
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Maquet Datascope Corp. - Cardiac Assist Division
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 Datascope Corp - Cardiac Assist Division · 1300 MacArthur Blvd. · Mahwah, NJ · 07430-2052
Is this the product you have?
- Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
- Lot codes and dates
- CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.
0998-00-0800-310998-UC-0800-310998-00-0800-320998-UC-0800-330998-00-0800-330998-UC-0800-520998-00-0800-340998-UC-0800-530998-00-0800-350998-UC-0800-550998-00-0800-450998-00-0800-520998-00-0800-530998-00-0800-55.
- Amount recalled
- 1,300 units
Where it was sold
- Nationwide
Why it was recalled
Power supply malfunction complaints related to suboptimal thermal management.
This product could cause temporary or reversible health problems — stop using it.
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