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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 10, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 25, 2005
Recall NumberZ-0731-04
Recall Event ID 28398
510(K)NumberK030083 
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
ProductVaxcel 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 ContactNancy 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 2		Other
ActionLetters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.
Quantity in Commerce786 units
DistributionShipments were nationwide to 158 medical facilities nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LJT
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