Device recall
Z-2505-2023: Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as…
FDA device recall · Class I · Abbott Medical
Key facts
| Recall number (Z-number) | Z-2505-2023 |
|---|---|
| Recall event | 92688 |
| Product | Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The 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… |
| Product code | LGW |
| Recalling firm | Abbott Medical |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P010032, P010032S096, P010032S151 |
| 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