FDA recall Z-2516-2026

Inspire Medical Systems Inc. · Class II · device

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 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

Worldwide distribution - US Nationwide and the country of Hong Kong.

Key facts

Status
Ongoing
Initiation date
2026-05-11
Report date
2026-06-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Golden Valley, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2516-2026