BEUDAMED
    FDA Enforcement Class II Terminated

    COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI

    Recall: Z-0832-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0832-2019
    Event ID
    81932
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AtriCure, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2019
    Initiation Date
    January 22, 2019
    Classification Date
    February 14, 2019
    Termination Date
    May 12, 2020
    Address
    7555 Innovation Way, N/A, Mason, OH, 45040-9695, United States

    Description

    COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI

    Reason

    There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

    Code Info

    UDI - 00818354013016 Lot Numbers - All lots within expiry

    Distribution

    AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia

    Quantity

    765 units