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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-1842-2010
Recall Event ID 55784
510(K)Number K012883  
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
Product Ultraflex Tracheobronchial Stent System. Covered - 12/40/25 Catalog Number: M00569450. 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: 9607764 9710083 9755805 9755807 9768417 9780170 9781422 9807265 9808558 9828820 11000667 1004425 11025299 11025360 11035316 11037596 11044751 11045323 11059724 11059725 11077979 11089728 11089854 11090227 11090550 11117598 11117617 11144052 11144056 11161115 11161176 11169321 11169323 11172782 11172787 11181008 11181009 11223594 11225459 11225720 11272056 11297064 11345267 11355632 11355901   11378895 11386405 11393437 11393640 11407218 11422202 11422204 11452161 11452169 11467545 11469425 11495261 11505745 11505746 11517843 11531097 11531581 11562738 11564170 11564171 11578121 11578189 11588544 11610966 11610970 11614256 11614257 11643232 11660971 11676049 11676053 11679449 11679451 11695932 11695933 11712716 11712961 11731528 11732301 11732307 11732314 11732394 11752640 11768968 11768970   11785578 11785719 11811929 11811934 11811937 11814041 11814045 11824069 11824070 11847070 11847071 11847073 11874721 11878009 11878014 11879531 11879532 11889175 11889176 11895277 11897357 11897881 11897882 11898065 11898066 11933117 11933119 12002822 12002823 12009747 12009749 12010111 12010112 12010113 12010114 12019195 12026993 12026994 12030473 12030476 12063603 12063940 12082473 12082620 12121290   12122287 12122291 12131566 12131570 12149801 12149802 12175989 12175992 12183041 12183441 12183444 12189993 12189996 12208356 12208546 12217885 12218027 12220981 12220982 12221573 12221574 12224645 12265914 12284768 12284863 12305129 12313575 12326181 12367818 12379040 12386123 12391778 12395945 12406564 12433678 12448651 12448652 12497202 12509682 12510968 12515884 12528713 12550761 12554815 12583260   12599567 12601779 12615974 12632667 12634089 12639184 12642784 12651488 12659759 12675648 12688236 12689565 12723744 12752291 12773198 12827715 12843003 12850405 12859761 12877471 12886396 12891104 12901510 12908947 12920883 12953537 13047823 13068377 13082945 13084926 13085100 13145598 13171637 13174862 13175884 13177730 13184625 13200422 13200511 13206064 13214653 13215008  
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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