BEUDAMED
    FDA Enforcement Class II Terminated

    Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.

    Recall: Z-0083-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0083-2014
    Event ID
    66322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    September 19, 2012
    Classification Date
    October 25, 2013
    Termination Date
    October 25, 2013
    Address
    3850 Brickway Blvd, N/A, Santa Rosa, CA, 95403-8223, United States

    Description

    Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.

    Reason

    Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.

    Code Info

    TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.

    Distribution

    International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.

    Quantity

    ~1000