Class 2 Device Recall Vaxcel Implantable Chest Ports with PASV Valve Technology

• Date Initiated by Firm: September 27, 2006
• Date Posted: March 15, 2007
• Recall Status: Terminated on November 26, 2007
• Recall Number: Z-0630-2007
• Recall Event ID: 37442
• 510(K)Number: K030083
• Product Classification: Implantable Vascular Access System - Product Code LJT
• Product: Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,
• Code Information: Lots 1137363, 1137364, 1137733, and 1137734
• FEI Number: 3017892510
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 10 Glens Falls Tech Park; Glens Falls NY 12801-3864
• For Additional Information Contact: Ms. Cindy Finney; 508-683-4678
• Manufacturer Reason for Recall: Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
• FDA Determined Cause: Other
• Action: On 9/27/06, Boston Scientific Corp. sent Urgent Medical Device Recall - Immediate Action Required letters (dated 9/27/06) via Federal Express to the 84 end users (medical facilities). The letters informed the users of the recall of the products due to a compromised sterile barrier. The letters instructed the users to immediately remove the affected lots from inventory, segregate them, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, return the product in an appropriate shipping carton, place the label on the outside of the shipping box, write the RGA # on the outside of the shipping carton, and return the recalled product to Boston Scientific Corp. Distribution Center, Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the user, and mailed or faxed back to Boston Scientific.
• Quantity in Commerce: Domestic - 194
• Distribution: Nationwide
• 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 = LJT