Inspire Medical Systems Recalls

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

Class I - Dangerous

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.

May 11, 2026 Implants & Prosthetics Nationwide View Details →

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Class I - Dangerous

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.

May 11, 2026 Implants & Prosthetics Nationwide View Details →

Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Class I - Dangerous

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Jul 31, 2024 Other Medical Devices Nationwide View Details →

Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Class I - Dangerous

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Jul 31, 2024 Other Medical Devices Nationwide View Details →

Inspire Model 3028, IV Implantable Pulse Generator

Class I - Dangerous

There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

May 16, 2024 Implants & Prosthetics Nationwide View Details →

Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).

Class I - Dangerous

Incorrect use-by date on the device registration/patient file labels.

Jun 12, 2018 Implants & Prosthetics Nationwide View Details →