FDA Device

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

Hazard

Power supply malfunction complaints related to suboptimal thermal management.

What You Should Do

Remedy

Maquet Inc. sent a recall letter/return response form dated 1/30/2015.

Affected by this recall?

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Products

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Brand
Maquet Datascope Corp Cardiac Assist Division
UPC
0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55.   CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.

Units Affected

1,300 units

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