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
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-2515-2026
- Recall initiated
- May 11, 2026
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