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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-1847-2010
Recall Event ID 55784
510(K)Number K012883  
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
Product Ultraflex Tracheobronchial Stent System. Covered - 16/60/45 Catalog Number: M00569520. 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: 9802438 9825051 9825183 11028463 11096877 11134525 11134526 11155266 11183180 11183184 11190929 11190931 11196982 11222307 11222308 11322699 11322808 11342536 11344628 11412495 11412744 11430286 11471040 11471041 11502877 11502879 11520626 11520627 11560886 11560890 11573251 11573299 11623680 11643650 11643653 11721511 11721514 11741999 11742422 11744401 11749506 11749507 11772333 11772334 11790411   11790658 11800001 11800005 11809015 11809019 11841642 11841643 11847105 11847108 11847140 11882025 11883117 11883118 11889174 11893116 11894017 11894018 11996479 12018168 12052699 12052822 12071288 12071290 12082047 12082049 12177977 12194992 12207113 12207118 12227747   12227750 12342973 12343830 12655844 12670341   12981613 12993133 12249944 12249956 12254267 12254270 12302279 12337166 12339597 12408719 12446794 12467731 12561009 12589371 12608594 12626429 12714003 12747821 12777144 12853912 12884155 12902924 12932464 13069362 13078443 13147743 13190260 13194410 13240287  
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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