BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

    Recall: Z-0621-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0621-2016
    Event ID
    72855
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2016
    Initiation Date
    December 10, 2015
    Classification Date
    January 8, 2016
    Termination Date
    March 8, 2016
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

    Reason

    The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.

    Code Info

    Serial numbers 209409, 209518, and 209609.

    Distribution

    International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.

    Quantity

    3