Recall Z-2159-2024 ยท MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
Inspire Medical Systems Inc.
Inspire Model 3028, IV Implantable Pulse Generator
| Date | Jun 21, 2024 (initiated May 16, 2024) |
| Status | Open, Classified |
| Reason | There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG, |
| Root cause | Process control |
| Action | Inspire Medical systems issued an URGENT Medical Device Correction notice to the affected healthcare providers on 05/16/2024 via FedEx overnight. The notice explains the potential problem with the device and risk to the patient and recommends the following actions: We recommend the following actions: " Notify affected patients of this voluntary recall. " Schedule your patient for a monitoring visit to confirm their Inspire therapy is working as intended through waveform and impedance analysis. Monitor patients for reports of variation in stimulation, a lack of therapy effectiveness, or an |
| Quantity | 24 devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.