BEUDAMED
    FDA Enforcement Class I Ongoing

    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011

    Recall: Z-2587-2024 · Reported August 28, 2024

    Enforcement

    Recall Number
    Z-2587-2024
    Event ID
    95069
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Inari Medical - Oak Canyon
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2024
    Initiation Date
    July 19, 2024
    Classification Date
    August 21, 2024
    Address
    6001 Oak Cyn, Irvine, CA, 92618-5200, United States

    Description

    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011

    Reason

    Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.

    Code Info

    UDI-DI:00850291007277. All lots. IU-01011 REV. C.

    Distribution

    Worldwide - US Nationwide distribution including in the states of PA, FL, GA, CA, IL, SC, NY, MN, UT, TN, WI, MI, KS, SD, AZ, AR, IN, KY, TX, AL, MS, DE, MA, OH, MO, WV, VA, NC, NV, CO, NE, OR, NM, NH, NJ, CT, ID, IA, WA, MD, OK, RI, DC, PR, LA, ND, VT and the countries of New Zealand, Chile, Australia.

    Quantity

    2488