BEUDAMED
    FDA Recall Terminated

    EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter

    Recall: Z-2854-2016 · Initiated August 9, 2016

    Recall

    Recall Number
    Z-2854-2016
    Event Number
    75046
    Firm
    EKOS Corporation
    FEI Number
    3001627457
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    August 9, 2016
    Terminated
    October 5, 2016
    Address
    11911 N Creek Pkwy S, Bothell, WA, 98011-8809

    Description

    EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter

    Reason

    The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.

    Action

    All affected consignees were contacted by e-mail on August 9, 2016, and asked to sequester implicated devices.

    Distribution

    Three international consignees - Germany, New Zealand and Taiwan

    Quantity

    10 units