BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX

    MDR report key: 24635045 · Received March 18, 2026

    Report

    Report Number
    1319211-2026-00074
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    June 1, 2016
    Report Date
    May 13, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    UDI-DI
    H787LVTX52130
    PMA / PMN Number
    K010767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4)

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PORT CATHETER, WITH MODEL NUMBER LVTX5213, AND LOT NUMBER 4993087. THE VORTEX DEVICE WAS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE VORTEX DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR THE PURPOSE OF TREATING PLAINTIFF'S PLASMAPHERESIS. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED TO (B)(6). BLOOD CULTURES WERE DRAWN AND RETURNED POSITIVE FOR INFECTION, NECESSITATING REMOVAL OF THE DEVICE. ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE DEVICE. THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196016 VORTEX PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC. LVTX5213 4993087 H787LVTX52130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening| O| H| R