BEUDAMED
    FDA Enforcement Class II Terminated

    ESSENTIO Pacemaker

    Recall: Z-3255-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3255-2018
    Event ID
    81001
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2018
    Initiation Date
    September 10, 2018
    Classification Date
    September 27, 2018
    Termination Date
    November 4, 2019
    Address
    4100 Hamline Ave N Bldg 3, Saint Paul, MN, 55112-5700, United States

    Description

    ESSENTIO Pacemaker

    Reason

    Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

    Code Info

    ESSENTIO SR model L100, ESSENTIO DR model L101, ESSENTIO MRI SR model L110, ESSENTIO MRI DR model L111, ESSENTIO EL DR model L121, and ESSENTIO MRI EL DR model L131

    Distribution

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