BEUDAMED
    FDA Enforcement Class I Terminated

    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

    Recall: Z-0234-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0234-2022
    Event ID
    88796
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 24, 2021
    Initiation Date
    September 20, 2021
    Classification Date
    November 18, 2021
    Termination Date
    October 5, 2023
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

    Reason

    7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

    Code Info

    Lot Number: 13F19J0656 13F19K0368 13F19K0342 13F20C0596 13F20F0081 13F20F0229 13F20F0509 13F20F0578 13F20G0177 13F20G0566 13F20H0531 13F20J0379 13F20L0514 13F21A0354 13F21C0081 13F21C0749 13F21D0870 13F21E0415 13F21F1188

    Distribution

    Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK

    Quantity

    1918 units