BEUDAMED
    FDA Recall Open, Classified

    NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

    Recall: Z-0025-2026 · Initiated August 29, 2025

    Recall

    Recall Number
    Z-0025-2026
    Event Number
    97524
    Firm
    Northeast Scientific Inc.
    FEI Number
    3005467144
    Product Code
    QTF
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 29, 2025
    Posted
    October 2, 2025
    Address
    2142 Thomaston Ave, Waterbury, CT, 06704-1013

    Description

    NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

    Reason

    Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

    Action

    Northeast Scientific notified consignees via an "URGENT: Medical Device Recall Notification" letter dated 8/29/2025 and email. Consignees were instructed to immediately discontinue use of affected products, quarantine and return any unused affected units, and complete and return the enclosed Recall Response Form, even if you no longer have any affected product. If product were further distributed, consignees were instructed to notify those customers immediately and ensure they also discontinue use and return the devices. Northeast Scientific will provide replacement product (if available) or credit for returned product. In addition, Northeast Scientific has initiated an investigation and is implementing corrective actions to prevent recurrence. If you have any questions or concerns, please reach out to your Northeast Scientific Sales Representative or contact us at [email protected] or 203-756-2111.

    Distribution

    US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.

    Quantity

    141 units