Class 2 Device Recall EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS

• Date Initiated by Firm: March 26, 2010
• Date Posted: May 14, 2010
• Recall Status: Terminated on April 23, 2012
• Recall Number: Z-1607-2010
• Recall Event ID: 55317
• 510(K)Number: K052964
• Product Classification: prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
• Product: EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
• Code Information: UPN M002004948580; Lot 11407455, Exp 12/2010.
• FEI Number: 2242352
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Susan Eichler Huston; 973-709-7487
• Manufacturer Reason for Recall: This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.
• FDA Determined Cause: Labeling mix-ups
• Action: The firm, MAQUET Cardiovascular, LLC, sent a "DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated March 23, 2010, to all customers via Federal Express. The letter describes the product, problem and action to be taken by customers. The customers were instructed to examine their stock immediately to determine if they have any of the affected product from the lot, discontinue dispensing the lot and complete and return by fax (973-709-6511) the enclosed Field Action Response Form whether or not they have any affected products. Please contact your local MAQUET cardiovascular sales representative or Customer Service at 1-888-880-2874 for the exchange.
• Quantity in Commerce: 1 unit
• Distribution: Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.
• 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 = DSY