Class 2 Device Recall AtriCure Reusable Clip Applier

• Date Initiated by Firm: January 23, 2014
• Date Posted: March 14, 2014
• Recall Status: Terminated on May 13, 2014
• Recall Number: Z-1209-2014
• Recall Event ID: 67572
• Product Classification: Applier, hemostatic clip - Product Code HBT
• Product: Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.
• Code Information: Lot Number MFR-0424-1
• Recalling Firm/ Manufacturer: Atricure Inc; 6217 Centre Park Drive; West Chester OH 45069
• For Additional Information Contact: Mr. Anupam K. Bedi; 513-755-4563
• Manufacturer Reason for Recall: The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.
• Quantity in Commerce: 46 units
• Distribution: Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.
• 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.