BEUDAMED
    FDA Recall 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 · Initiated May 22, 2020

    Recall

    Recall Number
    Z-2541-2020
    Event Number
    85775
    Firm
    Abbott
    FEI Number
    3005334138
    Product Code
    OAE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 22, 2020
    Terminated
    February 11, 2021
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    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

    Action

    The firm began notifying their consignees by letter on 05/22/2020. The notification reported the high rate of reported complaints for loss of contact force information while using the product, the risk to patient, and recommendations to avoid contact force failures.

    Distribution

    Worldwide distribution.

    Quantity

    84104 devices