Events

Recall of COBRA Fusion Ablation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AtriCure, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75373
  • Event Risk Class
    Class 2
  • Event Number
    Z-0653-2017
  • Event Initiated Date
    2016-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150159
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue - Product Code OCL
  • 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.
  • Action
    An Urgent: COBRA Fusion Ablation System Advisory Notification Letter with Acknowledgement Form was sent to all users. The letter described the issue and identified the affected device. Customers were asked to examine their inventory and determine if any affected product was on hand. All users, including those that the device may have been further distributed should be notified with a copy of the letter. Customers are to contact AtriCure customer service at 1-866-349-2342, and select option 6 to return any affected devices. The Device Notification Acknowledgement Form should be completed and returned as soon as possible.

Device

COBRA Fusion Ablation System
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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).
  • Manufacturer
    AtriCure, Inc.

Manufacturer

AtriCure, Inc.
  • Manufacturer Address
    AtriCure, Inc., 7555 Innovation Way, Mason OH 45040-9695
  • Manufacturer Parent Company (2017)
    Atricure Inc
  • Source
    USFDA