BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

    Recall: Z-2136-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2136-2021
    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

    Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

    Reason

    During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

    Code Info

    Endurant IIs Stent Graft System: Model (REF):ESBF3214C103E GTIN: 00643169439962 Serial Numbers: V29780773; V29780771; V29780759; Model (REF): ESBF3614C103EE GTIN: 00643169780460 Serial Numbers: V29781932; V29781933; V29781934; V29781935; V29781936; V29781937; V29781938; V29781939; V29781940; V29781941; V29781942; V29781943; V29781944; V29781945; V29781946; V29781947; V29781948; V29781951;

    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

    21 devices