BEUDAMED
    FDA Recall Open, Classified

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

    Recall: Z-0109-2026 · Initiated September 10, 2025

    Recall

    Recall Number
    Z-0109-2026
    Event Number
    97595
    Firm
    Abbott
    FEI Number
    3005334138
    Product Code
    OAE
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    September 10, 2025
    Posted
    October 10, 2025
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    Description

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

    Reason

    Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

    Action

    Abbott issued a Medical Device Advisory to its consignees on 09/10/2025 by letter delivered via Federal Express. The notice explained the issue, impact and associated risk to the patient and requested the following: "Action Requested/Recommendations/Next Steps . Continue following the product IFU by inspecting the packaging and catheter for damage and/or kinking prior to use. . Review the guidance in Appendix A information on proper removal technique of the TactiFlex" Ablation Catheter, Sensor Enabled" from the packaging tray, ensuring to inspect the electrodes and catheter tip carefully for integrity and overall condition prior to use. . Abbott has made changes to the packaging tray design to help mitigate tip damage during catheter removal from the packaging. The deployment of the new packaging has begun. Please complete the provided Acknowledgement Form with the assistance of your Abbott representative. This form ensures you are aware of the advisory notice and have been given an opportunity to ask questions. Please forward this notice to anyone in your organization who may need to be notified and maintain this notice for your records to ensure effectiveness of this communication. Should you have questions about this issue, please contact your local Abbott representative or Abbott Support at 1-855-478-5833 (U.S), 8:30 a.m. - 5:30 p.m. Central Standard Time, Monday thru Friday."

    Distribution

    Worldwide

    Quantity

    407 units