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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraflex Covered Tracheobronchial Stent System

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  Class 2 Device Recall Ultraflex Covered Tracheobronchial Stent System see related information
Date Initiated by Firm July 15, 2010
Date Posted August 31, 2010
Recall Status1 Terminated 3 on October 14, 2011
Recall Number Z-2328-2010
Recall Event ID 56331
510(K)Number K012883  
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
Product Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (16/6/4.5)
Material/UPN/Catalog Number: M00564840
Code Information Lot/Batch Number: 13439023  
Recalling Firm/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact
508-683-8000
Manufacturer Reason
for Recall
Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
FDA Determined
Cause 2
Process control
Action Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientific can be contacted at 1-508-683-4427.
Quantity in Commerce 9 units
Distribution Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden
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 = JCT and Original Applicant = BOSTON SCIENTIFIC CORP.
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