Device recall
Z-1055-2016: FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic…
FDA device recall · Class I · Arrow International, Inc., Division of Teleflex Medical Inc.
Key facts
| Recall number (Z-number) | Z-1055-2016 |
|---|---|
| Recall event | 73266 |
| Product | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle. |
| Product code | DSP |
| Recalling firm | Arrow International, Inc., Division of Teleflex Medical Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 12, 2021 |
| 510(k) numbers | K021462 |
| FEI number | 3010532612 |
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