FDAFDA · Alimentos y medicamentos·N.º oficial Z-2516-2026
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
Publicado el 24 de junio de 2026 · Inicio del retiro: 11 de mayo de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Inspire Medical Systems Inc.
- Distribuidor
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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