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 fl
Inspire Medical Systems Inc.
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Lot Code: Model 4063 (USA only lead)Model UDI-DI [4063] 10855728005793Model Inspire part number [4063] 900-013-001Model serial numbers D53393Model D61104 Model 4063 (Global lead)Model UDI-DI [4063] 10810098650295Model Inspire part number [4063] 900-013-003Model serial numbers D89539Model D89540Model D89543Model D89559Model D89563Model D89564Model D89577Model D8959UPC 10855728005793UPC 10810098650295Would you have heard about this one?
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