BEUDAMED
    FDA Enforcement Class II Ongoing

    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

    Recall: Z-0814-2024 · Reported January 31, 2024

    Enforcement

    Recall Number
    Z-0814-2024
    Event ID
    93711
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    St. Jude Medical, Atrial Fibrillation Division, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2024
    Initiation Date
    December 18, 2023
    Classification Date
    January 25, 2024
    Address
    1 Saint Jude Medical Dr, N/A, Saint Paul, MN, 55117-1789, United States

    Description

    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

    Reason

    When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.

    Code Info

    Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, Exp. 11/30/2024, GTIN 05415067034618.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KS, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WV. The country of Canada.

    Quantity

    483 units