Class 2 Device Recall PRO2 Device

• Date Initiated by Firm: September 22, 2016
• Create Date: November 09, 2016
• Recall Status: Terminated on February 15, 2018
• Recall Number: Z-0377-2017
• Recall Event ID: 75178
• 510(K)Number: K160454
• Product Classification: Clip, implantable - Product Code FZP
• Product: 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.
• Code Information: Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773
• Recalling Firm/ Manufacturer: AtriCure, Inc.; 7555 Innovation Way; Mason OH 45040-9695
• For Additional Information Contact: Mr. Anupam K. Bedi; 513-755-4563
• Manufacturer Reason for Recall: There is a potential for a component failure of the device which could necessitate medical intervention.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 298
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FZP