BEUDAMED
    FDA Enforcement Class I Terminated

    Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.

    Recall: Z-1981-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1981-2014
    Event ID
    68489
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    May 27, 2014
    Classification Date
    July 3, 2014
    Termination Date
    January 30, 2015
    Address
    6464 Sycamore Ct N, Maple Grove, MN, 55369-6032, United States

    Description

    Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.

    Reason

    The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.

    Code Info

    Lot Numbers: 569436, 569437, 569962, , 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.

    Distribution

    Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.

    Quantity

    8,580 total (US 5714)