BEUDAMED
    FDA Enforcement Class II Ongoing

    Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

    Recall: Z-2135-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2135-2021
    Event ID
    88158
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 4, 2021
    Initiation Date
    June 7, 2021
    Classification Date
    July 23, 2021
    Address
    3850 Brickway Blvd, N/A, Santa Rosa, CA, 95403-8223, United States

    Description

    Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

    Reason

    During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

    Code Info

    Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882

    Distribution

    U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.

    Quantity

    18 devices