BEUDAMED
    FDA Recall Terminated

    SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, Irvine, CA 92618., Intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary or carotid vasculature.

    Recall: Z-1162-2010 · Initiated January 21, 2010

    Recall

    Recall Number
    Z-1162-2010
    Event Number
    52299
    FEI Number
    2183870
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    January 21, 2010
    Posted
    March 18, 2010
    Terminated
    April 26, 2012
    Address
    Ev3 Inc. 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, Irvine, CA 92618., Intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary or carotid vasculature.

    Reason

    ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk Cutter Drivers (Model Number FG 02550) because of damage to the packaging.

    Action

    Consignees were sent an ev3 "Medical Device Recall" letter dated January 21, 2010. The letter was addressed to Cath Lab Manger/Risk Manager. The letter described the Issue Summary, Affected Product, and Required Action. The letter instructed customers to locate and remove from use the specified Cutter Driver(s). Customers are to complete and return the "Device Recall Field Action Reconciliation Form." An ev3 rep will assist in arranging for the return of all unused product and a replacement will be provided. Questions regarding the recall should be directed to ev3 Customer Service at 1-800-716-6700.

    Distribution

    Worldwide Distribution -- USA, with the exception of AK and VT, and countries of AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, FRANCE, GERMANY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANON, POLAND, SAUDI ARABIA, SOUTH KOREA, SPAIN, SWEDEN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.

    Quantity

    8,330