Class 3 Device Recall Boston Scientifc/Microvasive

• Date Initiated by Firm: January 28, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 28, 2006
• Recall Number: Z-0563-04
• Recall Event ID: 28313
• 510(K)Number: K030107 K012752
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
• Code Information: Lot Number: 6023979
• FEI Number: 3001451463
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Boston Scientific Pl; Natick MA 01760-1536
• For Additional Information Contact: Robert T. Miragliuolo; 508-652-5186
• Manufacturer Reason for Recall: Incorrect label states stent covered with 'Permalume Covering', product is uncovered
• FDA Determined Cause: Other
• Action: Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.
• Quantity in Commerce: 12 units
• Distribution: CA, GA, , MD, NY, OR, ND, PA Netherlands
• 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 = FGE