Device recall
Z-2159-2024: Inspire Model 3028, IV Implantable Pulse Generator
FDA device recall · Class I · Inspire Medical Systems Inc.
Key facts
| Recall number (Z-number) | Z-2159-2024 |
|---|---|
| Recall event | 94658 |
| Product | Inspire Model 3028, IV Implantable Pulse Generator |
| Product code | MNQ |
| Recalling firm | Inspire Medical Systems Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P130008, P130008S103 |
| 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