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Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 S
Recalled June 24, 2026 · FDA recall Z-2515-2026 · Inspire Medical Systems
Hazard
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. · FDA Class II
Units
50 impacted units
Sold at
Worldwide distribution - US Nationwide and the country of Hong Kong.
Description
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.
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
Manufacturer(s)
Inspire Medical Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →