Device recall
Z-1213-2009: 8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The…
FDA device recall · Class I · Arrow International, Inc.
Key facts
| Recall number (Z-number) | Z-1213-2009 |
|---|---|
| Recall event | 51080 |
| Product | 8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left… |
| Product code | DSP |
| Recalling firm | Arrow International, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 6, 2010 |
| 510(k) numbers | K000729, K010330, K021462, K040801 |
| FEI number | 3010532612 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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