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

Recall Summary Inspire Medical Systems is recalling the Inspire Respiratory Sensing Lead (Model 4340), a device used in implanted sleep apnea treatments, because it was labeled with incorrect expiration dates that extend beyond its validated three-year shelf life. The material in the device may degrade after the actual expiration date, which could require patients to undergo unplanned revision surgery. The recall affects devices distributed nationwide in the U.S. and in Hong Kong.

Recalling firm: Inspire Medical Systems Inc.
Product: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. 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/a24ae6be-3905-4c32-a18c-880363bb72d5