Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
FDA device recall Z-1140-2015 · posted 2015-02-23 · Terminated
Recall details
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Reason for recall
- Power supply malfunction complaints related to suboptimal thermal management.
- Action taken
- Maquet Inc. sent a recall letter/return response form dated 1/30/2015.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 1,300 units
- Distribution
- US Nationwide distribution
- Date initiated
- 2015-01-30
- Date posted
- 2015-02-23
- Date terminated
- 2017-09-29
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (K112372) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-15 |