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
Recall
- Recall Number
- Z-2516-2026
- Event Number
- 98990
- Firm
- Inspire Medical Systems Inc.
- FEI Number
- 3007666314
- Product Code
- MNQ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- May 11, 2026
- Posted
- June 18, 2026
- Address
- 5500 Wayzata Blvd, Ste 1600, Golden Valley, MN, 55416-1237
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
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.
Firm began notifying consignees on May 11, 2026. Letters were titled "URGENT Medical Device Correction." The firm requests consignees' assistance in removing affected product from clinical inventory and returning them to Inspire.
Worldwide distribution - US Nationwide and the country of Hong Kong.
10 impacted units