BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0956-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0956-2022
    Event ID
    89872
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    March 24, 2022
    Classification Date
    April 19, 2022
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209, United States

    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.

    Code Info

    Lot numbers: 8162700, 8164687, 8164730, 8172360, 8173365, 8173840, 8175413, 8177068, 8177349, 8177442, 8179358, 8179499, 8180723, 8180900, 8181043, 8182658, 8183581, 8183595, 8184393, 8184739, 8184817, 8186470, 8186747, 8186860, 8188124, 8188351, 8188844, 8190306, 8190438, 8191524, 8192181, 8192250, 8194325, 8195968, 8196343, 8196367, and 8197913. UDI (01)05415067027641(17)230331(10)xxxxxxx (lot number).

    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