BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 9, 2022

    Recall

    Recall Number
    Z-1344-2022
    Event Number
    90414
    Firm
    Abbott
    FEI Number
    3005334138
    Product Code
    OAE
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 9, 2022
    Posted
    July 7, 2022
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    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."

    Action

    The firm notified its consignees by hand delivered Medical Device Recall letter on 06/09/2022. The letter explained the problem and provided the following instructions: "Next Steps To help reduce risk, we recommend: " Do not use any remaining inventory from the affected lots listed in Appendix A. " Complete and return the accompanying Acknowledgement Form to Abbott. " Return all remaining unused affected devices to Abbott. Your Abbott representative can assist you in returning these devices and obtaining replacements. Please forward this notice to anyone within your organization who may need to be notified and maintain a record of this notice along with a copy of the completed Acknowledgement Form for your records."

    Distribution

    US Nationwide distribution.

    Quantity

    191 devices