BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0041-2025 · Initiated July 31, 2024

    Recall

    Recall Number
    Z-0041-2025
    Event Number
    95230
    Firm
    Inspire Medical Systems Inc.
    FEI Number
    3007666314
    Product Code
    MNQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 31, 2024
    Posted
    October 9, 2024
    Address
    5500 Wayzata Blvd, Ste 1600, Golden Valley, MN, 55416-1237

    Description

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

    Reason

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

    Action

    Inspire notified consignees on 07/31/2024, via emailed letter. Consignees were instructed to confirm the serial number on the lead is the serial number used to register the patient and to contact your Inspire representative if any labeling inconsistency is identified for complaint reporting.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.

    Quantity

    457 units