Class 2 Device Recall Ultraflex tracheobronchial Stent System

• Date Initiated by Firm: May 17, 2010
• Date Posted: June 25, 2010
• Recall Status: Terminated on October 20, 2011
• Recall Number: Z-1843-2010
• Recall Event ID: 55784
• 510(K)Number: K012883
• Product Classification: Prosthesis, tracheal, expandable - Product Code JCT
• Product: Ultraflex Tracheobronchial Stent System. Covered - 14/40/25 Catalog Number: M00569480. 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: 9675787 9678955 9678956 9685713 9700042 9701214 9708694 9718171 9718423 9787116 9806405 9806407 I 9825828 9825829 I 11002211 11002216 11004224 11022907 11026502 11037598 11038840 11098334 11099064 11114947 11115457 11125814 11125963 11129766 11154252 11154253 11165895 11186004 11189618 11189619 11215293 11221076 11221079 11223129 11223130 11286037 11286086 11324465 11365656 11373612 11379188 11390045 11413568 11413571 11453152 11453280 11471884 11471885 11495621 11497130 11516427 11517654 11521978 11526301 11556970 11556972 11605499 11605781 11609300 11613205 11613748 11613750 11628939 11646227 11646228 11663541 11664190 11715754 11715758 11718378 11719268 11719763 11733878 11733879 11748775 11755177 11755284 11776079 11781706 11781714 11806870 11809391 11809666 11819616 11819745 11823701 11826595 11836818 11839220 11839223 11841655 11841657 11847115 11847116 11860299 11860308 11863346 11863350 11875676 11875678 11946538 11946539 11947854 11948339 11948989 11959404 11959407 11962428 11962485 11974712 11986375 11994962 11995194 11995500 11997264 11997271 12053445 12082841 12106198 12106261 12113045 12123470 12123477 12144389 12144394 12155695 12155697 12165260 12165268 12195971 12196218 12216228 12216230 12221236 12221239 12224849 12236070 12262002 12292383 12292388 12312637 12347521 12348761 12349176 12350357 12357022 12359134 12364763 12387116 12392378 12402544 12407469 12422732 12426997 12433392 12452638 12452639 12480309 12512028 12516640 12548558 12566304 12583816 12587489 12605365 12620519 12626453 12637034 12641949 12653601 12676728 12694132 12708041 12754409 12761517 12783585 12847116 12851429 12866166 12869743 12882135 12899102 12928223 12928696 12939851 12955133 13015589 13036331 13068360 13088446 13112649 13122350 13122408 13125445 13213505 13213675 13217443 13231039
• 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: 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.