Device recall
Z-0822-2025: ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0822-2025 |
|---|---|
| Recall event | 95969 |
| Product | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331) |
| Product code | LWP |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P150012 |
| FEI number | 2124215 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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