Device recall
Z-2691-2017: Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO…
FDA device recall · Class II · St. Jude Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2691-2017 |
|---|---|
| Recall event | 77509 |
| Product | Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed… |
| Product code | LGW |
| Recalling firm | St. Jude Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2022 |
| PMA numbers | P010032 |
| 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