BEUDAMED
    FDA Enforcement Class I Terminated

    Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

    Recall: Z-2039-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2039-2020
    Event ID
    85649
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular Galway DBA Medtronic Ireland
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    May 12, 2020
    Classification Date
    May 27, 2020
    Termination Date
    March 10, 2022
    Address
    Parkmore Business Park West, N/A, Galway, N/A, N/A, Ireland

    Description

    Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

    Reason

    Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

    Code Info

    UDI: 00763000233815, All Lot Numbers

    Distribution

    US distribution in TX, WI, CA, NY, AL, and MI.

    Quantity

    103 units