BEUDAMED
    FDA Enforcement Class II 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 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2969-2018
    Event ID
    80372
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Inspire Medical Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 12, 2018
    Initiation Date
    June 12, 2018
    Classification Date
    September 4, 2018
    Termination Date
    May 21, 2019
    Address
    9700 63rd Ave N Ste 200, N/A, Maple Grove, MN, 55369-6202, United States

    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.

    Code Info

    UDI 10855728005434. The incorrect Use By Date of 2018-01-14 can be found in the literature packet that is in the box with the sterile tray/IPG. The literature packet contains the product/patient manuals, device registration form, and the device registration label set. The 3 large label sticker set with the device registration label set contains the incorrect use-by date.. Affected serial numbers in the customer's stock: NCR202227H, NCR202230H, NCR202238H, NCR202244H, NCR202245H, NCR202246H, NCR202247H, NCR202252H, NCR202253H, NCR202254H, NCR202255H, NCR202259H, NCR202260H, NCR202261H, NCR202264H, NCR202266H, NCR202267H, NCR202268H, NCR202269H, NCR202270H, NCR202272H, NCR202273H, NCR202274H, NCR202275H, NCR202276H, NCR202277H, NCR202278H, NCR202279H, NCR202281H, NCR202282H, NCR202283H, NCR202284H, NCR202285H, NCR202287H, NCR202294H, NCR202306H, NCR202307H, NCR202314H, NCR202315H, NCR202317H, NCR202320H, NCR202324H, NCR202325H, NCR202328H, NCR202336H, NCR202337H, NCR202338H, NCR202339H, NCR202466H, and NCR202467H; Serial numbers implanted: NCR202231H, NCR202233H, NCR202234H, NCR202236H, NCR202237H, NCR202239H, NCR202241H, NCR202242H, NCR202249H, NCR202250H, NCR202251H, NCR202256H, NCR202257H, NCR202258H, NCR202262H, NCR202265H, NCR202286H, NCR202291H, NCR202293H, NCR202296H, NCR202297H, NCR202300H, NCR202301H, NCR202302H, NCR202303H, NCR202304H, NCR202309H, NCR202310H, NCR202311H, NCR202312H, NCR202313H, NCR202318H, NCR202321H, NCR202322H, NCR202323H, NCR202326H, NCR202327H, NCR202329H, NCR202330H, NCR202331H, NCR202332H, NCR202333H, and NCR202334H.

    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