BEUDAMED
    FDA Recall Open, Classified

    Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).

    Recall: Z-1201-2021 · Initiated February 12, 2021

    Recall

    Recall Number
    Z-1201-2021
    Event Number
    87379
    Firm
    Medtronic Vascular, Inc.
    FEI Number
    3005364322
    Product Code
    MIH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 12, 2021
    Address
    3850 Brickway Blvd, Santa Rosa, CA, 95403-8223

    Description

    Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).

    Reason

    Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

    Action

    On or about 02/12/2021, the Recalling Firm initiated global verbal notifications to customers (risk managers and physicians) to immediately cease implants and quarantine any unused affected products.

    Distribution

    Worldwide distribution. US Nationwide, Italy, Denmark, Germany, Finland, Chile, Russian Federation, Norway, South Africa, New Zealand, Australia, United Kingdom, Switzerland, Austria, Netherlands, Spain, Portugal, France, Israel, Greece, Thailand, Ireland, Colombia, Canada, Hong Kong, Sweden, Belgium, Saudi Arabia, Malaysia, Singapore, Brazil, Macau, Luxembourg, Viet Nam, Taiwan, Croatia, Serbia, United Arab Emirates, Slovenia, Philippines, Poland, Japan, Costa Rica, Hungary, Korea, Slovakia, Malta, Bahrain, Kuwait, Qatar, Reunion, Honduras, Mauritius, India, Peru, El Salvador, Ukraine, Uruguay, Trinidad and Tobago.

    Quantity

    33,430 units