Recall Z-2516-2026 ยท MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
Inspire Medical Systems Inc.
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 flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerv
| Date | Jun 18, 2026 (initiated May 11, 2026) |
| Status | Open, Classified |
| Reason | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. |
| Root cause | Process control |
| Action | Firm began notifying consignees on May 11, 2026. Letters were titled "URGENT Medical Device Correction." The firm requests consignees' assistance in removing affected product from clinical inventory and returning them to Inspire. |
| Quantity | 10 impacted units |
| Distribution | Worldwide distribution - US Nationwide and the country of Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.