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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-1817-2010
Recall Event ID 55784
510(K)Number K012883  
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
Product Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog Number: M00568920. 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: 9660870 9660872 9683259 9684033 9825237 9825239 11020615 11021161 11045326 11046908 11092500 11092870 11100790 11101034 11179772 11180064 11221518 11286599 11291273 11397900 11586714 11586715 11630143 11630145 11665462 11665465 11682848 11682993 11722727 11722780 11740953 11740954 11767032 11767102 11791247 11791249 11808612 11809670 11858089 11858099 11858579 11858749 11864991 11864994 11890538   11890539 11993334 11993685 12054532 12054538 12066671 12066674 12088721 12088722 12119772 12119773 12150166 12150167 12166898 12167101 12201772 12201774 12233042 12233045 12239685 12239686 12273120 12273121 12371428 12386419 12441414 12554477 12607521 12624788 12652041 12728696 12732815 12746858 12753767 12781521 12832159 12836470 12849336 12862447 12933275 13081073 13110153 13119400 13203258 13236093 13318985  
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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