Device recall
Z-1140-2015: Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
FDA device recall · Class II · Maquet Datascope Corp - Cardiac Assist Division
Key facts
| Recall number (Z-number) | Z-1140-2015 |
|---|---|
| Recall event | 70510 |
| Product | Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) |
| Product code | DSP |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2017 |
| 510(k) numbers | K112372 |
| FEI number | 3001418283 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database