BEUDAMED
    FDA Enforcement Class II Ongoing

    ACCOLADE EL DR Pacemaker

    Recall: Z-0356-2018 · Reported January 24, 2018

    Enforcement

    Recall Number
    Z-0356-2018
    Event ID
    78787
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2018
    Initiation Date
    December 7, 2017
    Classification Date
    January 15, 2018
    Address
    4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    ACCOLADE EL DR Pacemaker

    Reason

    Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

    Code Info

    Model L321

    Distribution

    AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide

    Quantity

    N/A