BEUDAMED
    FDA Enforcement Class II Terminated

    RESONATE EL ICD DR, Model D433, Sterile.

    Recall: Z-0078-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0078-2018
    Event ID
    78323
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 15, 2017
    Initiation Date
    October 4, 2017
    Classification Date
    November 8, 2017
    Termination Date
    October 15, 2019
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    RESONATE EL ICD DR, Model D433, Sterile.

    Reason

    The devices have an incorrect firmware configuration.

    Code Info

    Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.

    Distribution

    The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

    Quantity

    12 devices