BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0083-2014 · Initiated September 19, 2012

    Recall

    Recall Number
    Z-0083-2014
    Event Number
    66322
    Firm
    Medtronic Vascular, Inc.
    FEI Number
    3005364322
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 19, 2012
    Posted
    October 25, 2013
    Terminated
    October 25, 2013
    Address
    3850 Brickway Blvd, Santa Rosa, CA, 95403-8223

    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.

    Action

    A Medical Device Information letter was sent to all affected customers on September 19, 2012. Additionally, all Medtronic Field Representatives were notified of the issue via a Field Memo

    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