Device recall
Z-1146-2021: ENROUTE Transcarotid Stent System REF SR-XXYY-CS
FDA device recall · Class II · Silk Road Medical Inc
Key facts
| Recall number (Z-number) | Z-1146-2021 |
|---|---|
| Recall event | 87196 |
| Product | ENROUTE Transcarotid Stent System REF SR-XXYY-CS |
| Product code | NIM |
| Recalling firm | Silk Road Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2023 |
| PMA numbers | P140026 |
| FEI number | 3007215228 |
At a glance
- None 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