Device recall
Z-0022-2018: Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable…
FDA device recall · Class II · St. Jude Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0022-2018 |
|---|---|
| Recall event | 78154 |
| Product | Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667 |
| Product code | LGW |
| Recalling firm | St. Jude Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2020 |
| PMA numbers | P010032, P010032S096, P010032S134 |
| FEI number | 1627487 |
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