BEUDAMED
    FDA Recall Terminated

    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.

    Recall: Z-0939-2009 · Initiated November 5, 2008

    Recall

    Recall Number
    Z-0939-2009
    Event Number
    50192
    Firm
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation
    FEI Number
    2024168
    Product Code
    LOX
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    November 5, 2008
    Posted
    February 3, 2009
    Terminated
    August 13, 2012
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.

    Reason

    The recall was initiated after Abbott Vascular received reports that, in a small percentage of cases, the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining th

    Action

    An Urgent Device Recall letter (dated November 6, 2008) with an Efficacy Check Reconciliation form was issued and hand-carried to affected customers by their respective Sales Representative who assisted in locating and returning the recalled units. The letter described the problem and informed customers that Abbott Vascular will replace returned recalled product with like product or with VOYAGER NC sizes when they become available. Additionally, customers were instructed to contact their Abbott Vascular local account representative to review their inventory, complete and return the attached Efficacy Check Reconciliation Form and return affected products to Abbott Vascular.

    Distribution

    Worldwide Distribution.

    Quantity

    126 units