Inspire Medical Systems recalls
3 official recalls and safety alerts involving Inspire Medical Systems since 2024-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Inspire Medical Systems or the relevant agency.
- 2026-06-24
USInspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The…
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…
FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice →- 2024-10-16
- US
Inspire Medical Systems Inc. recalls Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the countries of Belgium,…Official notice → - 2024-07-03
- US
Inspire Medical Systems Inc. recalls Inspire Model 3028, IV Implantable Pulse Generator
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,
FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the country of Germany.Official notice →