BEUDAMED
    FDA Enforcement Class II Terminated

    Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.

    Recall: Z-2749-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2749-2016
    Event ID
    74812
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    September 14, 2016
    Initiation Date
    June 15, 2016
    Classification Date
    September 7, 2016
    Termination Date
    February 6, 2017
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700, United States

    Description

    Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.

    Reason

    Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.

    Code Info

    serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.

    Distribution

    Distributed to the states of TX, NH, MA, PA, and MN.

    Quantity

    5