BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-2515-2026 · Initiated May 11, 2026

    Recall

    Recall Number
    Z-2515-2026
    Event Number
    98990
    Firm
    Inspire Medical Systems Inc.
    FEI Number
    3007666314
    Product Code
    MNQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 11, 2026
    Posted
    June 18, 2026
    Address
    5500 Wayzata Blvd, Ste 1600, Golden Valley, MN, 55416-1237

    Description

    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

    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.

    Action

    Firm began notifying consignees on May 11, 2026. Letters were titled "URGENT Medical Device Correction." The firm requests consignees' assistance in removing affected product from clinical inventory and returning them to Inspire.

    Distribution

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

    Quantity

    50 impacted units