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FDA-Device2026-06-24Class IIMISBRANDING

Inspire Medical Systems stimulation lead recalled for incorrect expiration dating

Inspire
EXPIRATION DATE ERRORNationwide distribution

Inspire stimulation lead recalled for incorrect expiration date

Inspire Medical Systems' Model 4063 stimulation leads are labeled with expiration dates that extend beyond their actual three-year shelf life. If a lead is used after its true expiration date, the material may degrade and could require unplanned revision surgery. A small number of units (10 total) have been affected worldwide.

  • If you have received an Inspire stimulation lead, contact your healthcare provider or Inspire Medical Systems to verify the correct expiration date for your specific unit.
  • Do not use any lead whose actual shelf life (three years from manufacture date) has passed, regardless of the label date.
  • Your implanting physician should verify all lot and serial numbers before implantation.
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.

Sold states
Worldwide distribution - US Nationwide and the country of Hong Kong.
Affected count
10 impacted units
Manufactured in
5500 Wayzata Blvd Ste 1600, Golden Valley, MN, United States
Products
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

Official notice

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

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