Recall Z-2515-2026 ยท MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
Inspire Medical Systems Inc.
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 that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a
| 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 | 50 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.