Device recall
Z-0297-2025: Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0297-2025 |
|---|---|
| Recall event | 95514 |
| Product | Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000. |
| Product code | OAE |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P220032 |
| FEI number | 2124215 |
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