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Recall Observatory FDA recall evidence

Device product

CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons

Z-1386-2017

December 23, 2016

Class II

Product summary

Firm
Maquet Datascope Corp - Cardiac Assist Division
Event
Event 76052
Status
Terminated
Classification
Class II
Quantity
8000
Official record key
device-enforcement:Z-1386-2017

Official wording

Reason: Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.

Code information: part number 0146-00-0097

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.