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U.S. Department of Health and Human Services

Class 1 Device Recall Marquet Heartstring II Proximal Seal System

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  Class 1 Device Recall Marquet Heartstring II Proximal Seal System see related information
Date Initiated by Firm May 05, 2010
Date Posted February 01, 2011
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = GUIDANT CORP.
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