Class 2 Device Recall AnastoClip GC Closure System

• Date Initiated by Firm: June 19, 2018
• Create Date: September 14, 2018
• Recall Status: Terminated on April 17, 2019
• Recall Number: Z-3042-2018
• Recall Event ID: 80627
• 510(K)Number: K173323
• Product Classification: Applier, hemostatic clip - Product Code HBT
• Product: AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
• Code Information: AGC2134
• FEI Number: 1220948
• Recalling Firm/ Manufacturer: LeMaitre Vascular, Inc.; 63 2nd Ave; Burlington MA 01803-4413
• For Additional Information Contact: Ms. Laurie Churchill; 781-425-1670
• Manufacturer Reason for Recall: The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
• FDA Determined Cause: Under Investigation by firm
• Action: On June 19, 2018, the firm sent Urgent Medical Device Recall letters to affected consignees. The letters informed customers of the product labeling issue. Customers were asked to complete the customer reply form and return it to the firm, and to forward the recall to any other facilities where product had been distributed. After the customer service department receives the completed form, they will contact the customer to arrange for a return of the recalled product at no charge to the customers. Customer service will also arrange for customers to receive replacement product. If you have any questions concerning this recall, please contact Ms. Rose Lerer, Senior Quality Engineer, 781-425-1671 or rlerer@lemaitre.com.
• Distribution: Distributed to accounts in FL, NV, OK, SC, and TX.
• 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 = HBT