Inspire Medical Systems Inc. — Class II: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/C
Inspire Medical Systems Inc. has initiated a Class II recall for its Inspire Stimulation Lead (Model 4063) due to labeling that displays an incorrect 'Use By Date' exceeding the validated three-year shelf life. Use of the device beyond its validated life may lead to material degradation and necessitate unplanned revision surgery.
Inspire Medical Systems Inc., healthcare providers performing hypoglossal nerve stimulation implants, and professionals in medical device quality, regulatory compliance, and clinical risk management.
This recall underscores the critical importance of aligning labeling systems with primary stability data. For implantable leads, material degradation past validated dates presents a significant clinical risk of premature device failure and surgical intervention. Regulatory teams may view this as a failure in labeling controls or the design transfer process where validated shelf-life parameters are translated into production outputs.
Perform an immediate inventory audit to identify leads with labels exceeding the three-year validated shelf life. Follow established CAPA procedures to address the labeling error and ensure future manufacturing Date-to-Use-By calculations align strictly with validated stability data. Provide updated instructions to clinical sites regarding the risks of implanting expired units.
Class II. Reason: 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.. Product: 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. Firm: Inspire Medical Systems Inc. (Golden Valley MN United States). Status: Ongoing.
Open in openFDA / FDA.gov