BEUDAMED
    FDA Enforcement Class II Terminated

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    Recall: Z-0813-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0813-2017
    Event ID
    75785
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oscor, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 28, 2016
    Initiation Date
    October 5, 2016
    Classification Date
    December 19, 2016
    Termination Date
    July 26, 2019
    Address
    3816 Desoto Blvd, N/A, Palm Harbor, FL, 34683-1618, United States

    Description

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    Reason

    Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

    Code Info

    Lot #'s: C1-08939 Exp. May 19, 2017, C1-08985 Exp. June 1, 2017, C1-09584 Exp. January 18, 2018, and C1-10120 Exp. April 17, 2018

    Distribution

    Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

    Quantity

    215