BEUDAMED
    FDA Recall Terminated

    Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).

    Recall: Z-2969-2018 · Initiated June 12, 2018

    Recall

    Recall Number
    Z-2969-2018
    Event Number
    80372
    Firm
    Inspire Medical Systems Inc.
    FEI Number
    3007666314
    Product Code
    MNQ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 12, 2018
    Terminated
    May 21, 2019
    Address
    9700 63rd Ave N, Ste 200, Maple Grove, MN, 55369-6202

    Description

    Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).

    Reason

    Incorrect use-by date on the device registration/patient file labels.

    Action

    The firm's sales team members called all of the affected implanting surgeons between 6/12-14/2018 to discuss the recall. The recalling firm issued "Dear Health Care Provider" letters dated 6/15/2018 via certified mail on 6/15/2018 to all implanting surgeons and hospital customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-763-205-7974.

    Distribution

    US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI.

    Quantity

    93 devices