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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-1846-2010
Recall Event ID 55784
510(K)Number K012883  
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
Product Ultraflex Tracheobronchial Stent System. Covered - 16/40/25 Catalog Number: M00569510. 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: 9814671 9815162 9821720 9821721 11019719 11039445 11040234 11061780 11061785 11065663 11065861 11126505 11164159 11164696 11172644 11172645 11209605 11209607 11460095 11463663 11489095 11489097 11501816 11550941 11564168 11595564 11614158 11659024 11668908 11668909 11713151 11717250 11744122 11748292 11752496 11791002 11791007 11808017 11821349 11828775 11828777 11887496 11908857 11966713 11966717   11986377 11987450 12000306 12070034 12070035 12084800 12084942 12112346 12112577 12122997 12122999 12144572 12144574 12158228 12158364 12201191 12202918 12235143 12235147 12237385 12251546 12251548 12257182 12338350 12339366 12342124 12350106 12376903 12419809 12460961 12462132 12511148 12545474 12548330 12589195 12625202 12635828 12656070 12673087 12678279 12695756 12778940 12884818 12912157 12971590   13003857 13022422 13064129 13074777 13114616 13117346 13133435 13194248 13194249 13200250 13222371  
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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