Recall Z-0041-2025 ยท MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
Inspire Medical Systems Inc.
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
| Date | Oct 9, 2024 (initiated Jul 31, 2024) |
| Status | Open, Classified |
| Reason | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| Root cause | Process control |
| Action | Inspire notified consignees on 07/31/2024, via emailed letter. Consignees were instructed to confirm the serial number on the lead is the serial number used to register the patient and to contact your Inspire representative if any labeling inconsistency is identified for complaint reporting. |
| Quantity | 457 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.