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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-1853-2010
Recall Event ID 55784
510(K)Number K012883  
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
Product Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580. 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 Number: 9702666 9713744 9815286 9815735 9827448 11023940 11048031 11048060 11090552 11091623 11100787 11100789 11130407 11130409 11169593 11199527 11199535 11280856 11280880 11341089 11341176 11432241 11432242 11449851 11450165 11478740 11478748 11508004 11508006 11544543 11544548 11580979 11581280 11588652 11588654 11638613 11648449 11648451 11712580 11712582 11713706 11714530 11749295 11749401 11768151   11768153 11788880 11795319 11795584 11805726 11805727 11844354 11845372 11847118 11882868 11882870 11940557 11965234 11965643 11975795 11976130 12031087 12068298 12068464 12085102 12085111 12128423 12166213 12198180 12198183 12199117 12199299 12238417 12253760 12272254 12321133 12376164 12394715 12445215 12467922 12500371 12552399 12572753 12600206 12623799 12639192 12668979 12715336 12744279 12752674   12833389 12846410 12860388 12877943 12917360 12954186 12956938 12974683 12996101 13051719 13059606 13068104 13074855 13076093 13115832 13142196 13181128 13186398 13191494 13281348 13282288  
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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