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High risk Medical DevicesClass II

Inspire Stimulation Lead 4063 Recall

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire

Updated May 11, 2026

Inspire Stimulation Lead (Model 4063) devices are labeled with incorrect expiration dates that extend beyond their validated three-year shelf life. Using an expired device may cause material degradation, leading to unplanned or premature revision surgery.

Is the Inspire Medical Systems Inc. recalled? Yes. This product was recalled by FDA on May 11, 2026. Details below.

What is recalled

Inspire Stimulation Lead, Model 4063. These are implantable leads designed to deliver stimulation to the hypoglossal nerve for treatment of obstructive sleep apnea.

Am I affected

You are affected if you have an Inspire Stimulation Lead Model 4063 with a Use By Date labeled on the package that extends more than three years from the manufacturer date printed on the device.

What to do right now

Contact Inspire Medical Systems Inc. immediately to verify the correct expiration date of your device. Do not use the device if the labeled expiration date is incorrect. Your doctor or the manufacturer can advise whether your specific device needs to be replaced before implantation or revision.

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.

Brands affected

Inspire Medical Systems Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2516-2026
Classification
Class II
Recalled
May 11, 2026
Read the official notice

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