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 nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A
Class II
- Recalling firm
- Inspire Medical Systems Inc.
- Reason for recall
- 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.
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- State
- MN
- Status
- Ongoing
- Recall number
- Z-2516-2026
- Recall initiated
- May 11, 2026
View on openFDA