Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
This recall has been terminated (originally issued February 23, 2015).
- Recall Initiated
- January 30, 2015
- Posted
- February 23, 2015
- Terminated
- September 29, 2017
- Recall Number
- Z-1140-2015
- Quantity
- 1,300 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Power supply malfunction complaints related to suboptimal thermal management.
Distribution
US Nationwide distribution
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
Maquet Inc. sent a recall letter/return response form dated 1/30/2015.
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