Inspire Medical Systems Inc.: Stimulator, Hypoglossal Nerve, Implanted, Apnea

Recall Summary Inspire Medical Systems is recalling Inspire Stimulation Lead Model 4063, a device implanted to treat obstructive sleep apnea by stimulating the hypoglossal nerve. The leads are labeled with incorrect expiration dates that extend beyond their validated three-year shelf life, which could cause the material to degrade and potentially require unplanned revision surgery. The recall affects devices distributed nationwide in the US and in Hong Kong.

Recalling firm: Inspire Medical Systems Inc.
Product: 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
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.
Classification: Class III
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-05-11
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong.

Recall details on Nibble Recalls: https://trynibble.app/recalls/25d039a4-7c2b-4019-aa45-f17e3ce725a5