BEUDAMED
    FDA Enforcement Class II Terminated

    ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

    Recall: Z-0879-2015 · Reported January 7, 2015

    Enforcement

    Recall Number
    Z-0879-2015
    Event ID
    69965
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ev3, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 7, 2015
    Initiation Date
    December 4, 2014
    Classification Date
    December 29, 2014
    Termination Date
    July 17, 2015
    Address
    4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States

    Description

    ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

    Reason

    Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.

    Code Info

    Lot # 9922795

    Distribution

    International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.

    Quantity

    24