Device recall
Z-2969-2018: Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep…
FDA device recall · Class II · Inspire Medical Systems Inc.
Key facts
| Recall number (Z-number) | Z-2969-2018 |
|---|---|
| Recall event | 80372 |
| Product | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe… |
| Product code | MNQ |
| Recalling firm | Inspire Medical Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2019 |
| 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