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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 10, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 25, 2005
Recall Number Z-0734-04
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, STD PS port, Implantable Port System, Model # M001453660, Catalog #45-366
Code Information 866764, 879997, 885445, 886400, 887133, 888995, 903726
Recalling Firm/
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Nancy Cutino
Manufacturer Reason
for Recall
Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
FDA Determined
Cause 2
Action Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.
Quantity in Commerce 308 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.