BEUDAMED
    FDA Recall Open, Classified

    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

    Recall: Z-2239-2023 · Initiated June 8, 2023

    Recall

    Recall Number
    Z-2239-2023
    Event Number
    92585
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    DTK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 8, 2023
    Posted
    July 27, 2023
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

    Reason

    There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    3.0