Device recall
Z-2273-2025: Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-2273-2025 |
|---|---|
| Recall event | 97243 |
| Product | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID… |
| Product code | NIM |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P050019 |
| FEI number | 3002095335 |
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