Device recall
Z-2515-2026: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory…
FDA device recall · Class II · Inspire Medical Systems Inc.
Key facts
| Recall number (Z-number) | Z-2515-2026 |
|---|---|
| Recall event | 98990 |
| Product | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane… |
| 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