BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.

    Recall: Z-1375-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1375-2016
    Event ID
    73630
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    March 15, 2016
    Classification Date
    April 12, 2016
    Termination Date
    August 22, 2016
    Address
    1600 West Merit Parkway, N/A, South Jordan, UT, 84095, United States

    Description

    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.

    Reason

    Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50¿ curve, rather than the correct 86¿ curve

    Code Info

    Lot Q823423, Exp 7/31/2018

    Distribution

    Distributed to one customer in the US.

    Quantity

    25