Z-2516-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- May 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 impacted units
Product Description
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 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.
Code Information
Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbers D53393, D61104 Model 4063 (Global lead); UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959