BEUDAMED
    FDA Recall Open, Classified

    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

    Recall: Z-0956-2022 · Initiated March 24, 2022

    Recall

    Recall Number
    Z-0956-2022
    Event Number
    89872
    Firm
    Abbott
    FEI Number
    3005334138
    Product Code
    OAE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 24, 2022
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    Description

    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

    Reason

    Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

    Action

    The recalling firm issued letters dated 3/24/2022 on 3/24/22 via hand-delivery. The letters explained the issue, the impact and associated risks, and the steps to reduce risk. The steps included not using any of the remaining inventory of the affected lots listed in Appendix A, complete and return the accompanying Acknowledgment Form, and return all remaining unused affected devices to the recalling firm. The consignee is informed their Abbott representative can assist in returning these devices and obtaining replacements. The notice is to be forwarded to anyone within their organization who may need to be notified and a copy of the notice should be kept along with the completed Acknowledgment Form for their records.

    Distribution

    Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.

    Quantity

    2,134 devices