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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraflex tracheobronchial Stent System

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  Class 2 Device Recall Ultraflex tracheobronchial Stent System see related information
Date Initiated by Firm May 17, 2010
Date Posted June 25, 2010
Recall Status1 Terminated 3 on October 20, 2011
Recall Number Z-1830-2010
Recall Event ID 55784
510(K)Number K012883  
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
Product Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog Number: M00569090. Single Use, Rx only. Boston Scientific, Natick, MA 01760.

Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
Code Information Lot Numbers: 9657941 9658105 9696978 9737028 9822915 9822918 11084897 11143496 11150354 11150355 11252315 11253322 11485085 11485088 11540266 11540268 11603795 11605485 11640294 11640296 11716316 11723616 11775490 11808563 11808564 11871267 11871268 12026243 12026244 12049248 12049249 12107672 12150138 12150139 12206312 12206316 12239697 12239880 12271577 12271579 12407609 12441821 12494755 12518886 12570571   12601507 12604799 12621237 12645436 12697020 12889006 12957090 12986896 13116725    
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact same
508-683-8000
Manufacturer Reason
for Recall		 Suture related device failures during deployment and repositioning of the stent
FDA Determined
Cause 2		 Device Design
Action Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.
Distribution Worldwide Distribution - Only US distributed product is affected by recall
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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