Recall

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

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 details: 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 obstruc...

Active Official source

Verification

Official-source record

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Agency
FDA
Record ID
Z-2516-2026
Canonical
https://claimwatch-mvp.vercel.app/item/inspire-medical-systems-inc-brand-name-inspire-medical-systems-inc-product-name-inspire-st/

What happened?

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 details: 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 obstruc...

Who may be affected?

Worldwide distribution - US Nationwide and the country of Hong Kong.

What should consumers do?

Affected quantity: 10 impacted units

Matched search terms

No search trend terms attached yet.

FAQ

Is this page official?

No. ClaimWatch links to official sources and marks whether a page is verified or still being monitored.

Is this legal, medical, or financial advice?

No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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