Events

Recall of PRO2 Device

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
    75178
  • Event Risk Class
    Class 2
  • Event Number
    Z-0377-2017
  • Event Initiated Date
    2016-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150127
  • 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
    Clip, implantable - Product Code FZP
  • Reason
    There is a potential for a component failure of the device which could necessitate medical intervention.
  • Action
    AtriCure sent an Urgent Advisory Notice dated September 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and determine if they have any affected product. If so customers should ensure that all users of the affected devices are aware of the Advisory Notice. If customers further distributed the product, they should identify their customers and notify them at once of the Advisory Notice. Any units from the affected lots should be returned to AtriCure, Inc. Customers should contact AtriCure customer service at 1-866-349-2342, and select option 6 to return any affected product(s). Customers were asked to complete and return the enclosed Device Notification Acknowledgement Form as soon as possible. Customers with questions should call 513-755-4563.

Device

PRO2 Device
  • Model / Serial
    Model Numbers: PRO235, PRO240, PRO245 and PRO250  Lot Numbers: 65622 to 66773
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland
  • Product Description
    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip || Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
  • 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