BEUDAMED
    FDA Recall 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 · Initiated June 15, 2016

    Recall

    Recall Number
    Z-2749-2016
    Event Number
    74812
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 15, 2016
    Posted
    September 7, 2016
    Terminated
    February 6, 2017
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    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.

    Action

    As we considered the value of a direct physician communication we have not identified any information that would be of value to the physician because device performance and behavior remain unchanged.

    Distribution

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

    Quantity

    5