Reported Jun 24, 2026 · Ongoing
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product…
Inspire Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inspire Medical Systems Inc. · 5500 Wayzata Blvd Ste 1600 · Golden Valley, MN · 55416-1237
Is this the product you have?
- Brand NameInspire Medical Systems, Inc
- Product NameInspire
- stimulation Lead Model/Catalog Number4063
- Product DescriptionThe 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)
- ComponentN/A
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 4063Lot Code: (USA only lead) — 10855728005793UDI-DI [4063] 10855728005793 — Inspire part number [4063] 900-013-001 4063serial numbers D53393, D61104 (Global lead) — 10810098650295UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003 — serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959 - Amount recalled
- 10 impacted units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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