Device recall
Z-0879-2021: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0879-2021 |
|---|---|
| Recall event | 87014 |
| Product | EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD) |
| Product code | LWS |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 23, 2024 |
| PMA numbers | P110042, P110042S077 |
| 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