Class 1 Device Recall Marquet Heartstring II Proximal Seal System

• Date Initiated by Firm: May 05, 2010
• Date Posted: February 01, 2011
• Recall Status: Terminated on June 21, 2011
• Recall Number: Z-0940-2011
• Recall Event ID: 56868
• 510(K)Number: K022880
• Product Classification: Clamp, vascular - Product Code DXC
• Product: Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
• Code Information: Lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Nitya Narayanan; 973-709-7498
• Manufacturer Reason for Recall: Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
• FDA Determined Cause: Process design
• Action: The firm, MAQUET Getinge Group, sent an "URGENT DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 5, 2010, to all customers via Federal Express. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to immediately examine their stocks to determine if they have any of the affected product, if found, discontinue dispensing (distributing) the lot and complete the Field Action Response Form; immediately contact accounts if they acted as a distributor, and acknowledge receipt of this notification whether or not they have any affected products by completing the Field Action Response Form via fax to (U.S.): 1-888-899-2874. If you have any additional questions, please contact your local MAQUET Cardiovascular sales representative or our Customer Service at 1-888-880-2874.
• Quantity in Commerce: 1630
• Distribution: Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
• 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 = DXC