Class 2 Device Recall

• Date Initiated by Firm: February 10, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 25, 2005
• Recall Number: Z-0731-04
• Recall Event ID: 28398
• 510(K)Number: K030083
• Product Classification: Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
• Product: Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model # M001452150, Catalog #45-215
• Code Information: 866561, 876068, 885270, 885444, 886041, 886398, 887738, 888993, 889702, 890163, 903721
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Boston Scientific Pl; Natick MA 01760-1536
• For Additional Information Contact: Nancy Cutino; 508-652-5066
• Manufacturer Reason for Recall: Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
• FDA Determined Cause: Other
• Action: Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.
• Quantity in Commerce: 786 units
• Distribution: Shipments were nationwide to 158 medical facilities 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 and Original Applicant = BOSTON SCIENTIFIC CORP.