BEUDAMED
    FDA Enforcement Class II Terminated

    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.

    Recall: Z-2541-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2541-2020
    Event ID
    85775
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    May 22, 2020
    Classification Date
    July 9, 2020
    Termination Date
    February 11, 2021
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209, United States

    Description

    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.

    Reason

    High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter

    Code Info

    All batch numbers with an expiration date of April 25, 2020

    Distribution

    Worldwide distribution.

    Quantity

    84104 devices