Recall Z-1140-2015 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Datascope Corp - Cardiac Assist Division
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
| Date | Feb 23, 2015 (initiated Jan 30, 2015) |
| Status | Terminated |
| Reason | Power supply malfunction complaints related to suboptimal thermal management. |
| Root cause | Under Investigation by firm |
| Action | Maquet Inc. sent a recall letter/return response form dated 1/30/2015. |
| Quantity | 1,300 units |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP Cardiac Assist, Maquet Cardiovascular, LLC, Sep 15, 2011 |