Device recall
Z-2516-2026: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead…
FDA device recall · Class II · Inspire Medical Systems Inc.
Key facts
| Recall number (Z-number) | Z-2516-2026 |
|---|---|
| Recall event | 98990 |
| Product | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a… |
| Product code | MNQ |
| Recalling firm | Inspire Medical Systems Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P130008 |
| 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