BEUDAMED
    FDA Recall Terminated

    Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary

    Recall: Z-0620-2016 · Initiated December 10, 2015

    Recall

    Recall Number
    Z-0620-2016
    Event Number
    72855
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWP
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    December 10, 2015
    Posted
    January 8, 2016
    Terminated
    March 8, 2016
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. 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.

    Action

    The firm, Boston Scientific, sent a "Medical Device Retrieval" letter dated December 2015 to its Consignees on 12/10/2015. The letter described the problem, product involved in the recall and actions to be taken. The consignees were instructed to immediately segregate the product to ensure that it will not be used, obtain an IAN (inventory authorization number) from Boston Scientific's Logistics Department by email at [email protected]; return it back to Boston Scientific-Clonmel Cashel Rd., Clonmel Co Tipperary Ireland. If you have any questions about this retrieval contact your local Boston Scientific representative or a Technical Services representatives at 1-800-CARDIAC (227-3422) [email protected] or [email protected].

    Distribution

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

    Quantity

    5