Device recall
Z-0041-2025: Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway…
FDA device recall · Class II · Inspire Medical Systems Inc.
Key facts
| Recall number (Z-number) | Z-0041-2025 |
|---|---|
| Recall event | 95230 |
| Product | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. |
| Product code | MNQ |
| Recalling firm | Inspire Medical Systems Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3007666314 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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