BEUDAMED
    FDA Enforcement Class II Terminated

    COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).

    Recall: Z-0653-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0653-2017
    Event ID
    75373
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AtriCure, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 30, 2016
    Initiation Date
    September 22, 2016
    Classification Date
    November 22, 2016
    Termination Date
    February 8, 2018
    Address
    7555 Innovation Way, N/A, Mason, OH, 45040-9695, United States

    Description

    COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).

    Reason

    Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.

    Code Info

    Specifically all lots manufactured prior to February 2016. This information can be identified as the symbol for "date of manufacture" on the product label as: MM-YYYY, e.g. 02-2016 or earlier.

    Distribution

    Worldwide Distribution -- USA, in the following states AL, AR, AZ, CA, CO, CT, GA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI, & VA; and, to the countries of Albania, Australia, Belgium, France, Germany, Ireland, Italy, Norway, Netherlands, Poland, Sweden, Turkey, United Arab Emirates, & United Kingdom.

    Quantity

    5,263