FDA-Device2026-06-24Class IIMISBRANDING
Inspire Respiratory Sensing Lead Model 4340 recalled for incorrect expiration dating
What this means
Inspire Medical Systems' Respiratory Sensing Lead (Model 4340) was labeled with expiration dates that extend beyond the validated three-year shelf life. If the device is used after its actual expiration date, the material may degrade and could require unplanned revision surgery.
- Check your implanted device paperwork for the serial number and Use By date
- Contact your surgeon if you received this device with a serial number listed in the recall
- Do not use any unit past its three-year shelf life from the manufacturer date
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Hong Kong.
Affected count
50 impacted units
Manufactured in
5500 Wayzata Blvd Ste 1600, Golden Valley, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2515-2026Want us to check the next one for you?
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