Device recall
Z-0482-2015: Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for…
FDA device recall · Class II · Stryker Neurovascular
Key facts
| Recall number (Z-number) | Z-0482-2015 |
|---|---|
| Recall event | 69669 |
| Product | Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion. |
| Product code | NJE |
| Recalling firm | Stryker Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 12, 2015 |
| FEI number | 3008853977 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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