BEUDAMED
    FDA Enforcement Class II Terminated

    lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

    Recall: Z-1517-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1517-2013
    Event ID
    65289
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invatec Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    March 4, 2009
    Classification Date
    June 6, 2013
    Termination Date
    June 10, 2013
    Address
    3101 Emrick Blvd, N/A, Bethlehem, PA, 18020-8037, United States

    Description

    lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

    Reason

    Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

    Code Info

    Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801

    Distribution

    Nationwide Distribution

    Quantity

    177 units