Device product

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

Z-1140-2015

January 30, 2015

Class II

Product summary

Firm: Maquet Datascope Corp - Cardiac Assist Division
Event: Event 70510
Status: Terminated
Classification: Class II
Quantity: 1,300 units
Official record key: device-enforcement:Z-1140-2015

Official wording

Reason: Power supply malfunction complaints related to suboptimal thermal management.

Code information: 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.

Distribution pattern: US Nationwide distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Power supply malfunction complaints related to suboptimal thermal management.