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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientifc/Microvasive

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  Class 3 Device Recall Boston Scientifc/Microvasive see related information
Date Initiated by Firm January 28, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = BOSTON SCIENTIFIC CORP.
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