BEUDAMED
    FDA Enforcement Class II Ongoing

    Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

    Recall: Z-0290-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0290-2022
    Event ID
    88951
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 1, 2021
    Initiation Date
    October 15, 2021
    Classification Date
    November 24, 2021
    Address
    3850 Brickway Blvd, Santa Rosa, CA, 95403-8223, United States

    Description

    Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

    Reason

    During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

    Code Info

    Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    2 devices