BEUDAMED
    FDA Enforcement Class II Terminated

    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

    Recall: Z-1976-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1976-2021
    Event ID
    88028
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    April 28, 2021
    Classification Date
    June 28, 2021
    Termination Date
    April 5, 2024
    Address
    3850 Brickway Blvd, N/A, Santa Rosa, CA, 95403-8223, United States

    Description

    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

    Reason

    Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

    Code Info

    Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;

    Distribution

    U.S. Nationwide distribution in the state of GA. O.U.S.: None

    Quantity

    3 devices