BEUDAMED
    FDA Enforcement Class II Ongoing

    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.

    Recall: Z-1344-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1344-2022
    Event ID
    90414
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2022
    Initiation Date
    June 9, 2022
    Classification Date
    July 7, 2022
    Address
    5050 Nathan Ln N, N/A, Plymouth, MN, 55442-3209, United States

    Description

    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.

    Reason

    When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."

    Code Info

    UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811

    Distribution

    US Nationwide distribution.

    Quantity

    191 devices