Device recall
Z-0231-2022: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR…
FDA device recall · Class I · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-0231-2022 |
|---|---|
| Recall event | 88796 |
| Product | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and… |
| Product code | DXE |
| Recalling firm | Arrow International Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 5, 2023 |
| 510(k) numbers | K011056 |
| FEI number | 3015859709 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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