Class 2 Device Recall Ultraflex Esophageal Stent System

• Date Initiated by Firm: May 17, 2010
• Date Posted: June 25, 2010
• Recall Status: Terminated on October 20, 2011
• Recall Number: Z-1869-2010
• Recall Event ID: 55784
• 510(K)Number: K032930
• Product Classification: Prosthesis, esophageal - Product Code ESW
• Product: Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/15/12. Catalog Number M00513860. Single Use, Rx only. Boston Scientific, Natick, MA 01760.; ; Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
• Code Information: Lot Number: 11719602 11722423 11729258 11732395 11735494 11740570 11748770 11752427 11769386 11773338 11777262 11781839 11782525 11787376 11789954 11793314 11800869 11802155 11802156 11802392 11803116 11805913 11809388 11811477 11819214 11820113 11821346 11825934 11829503 11837699 11838728 11840630 11845911 11845999 11846186 11846954 11859652 11861339 11861519 11876752 11880158 11881724 11882311 11888837 11890230 11890763 11893928 11896626 11900853 11914975 11943410 11944929 11945718 11947640 11951128 11961828 11964989 11968323 11974818 11978689 11981527 11981530 11985023 11987143 11992549 11995198 11997771 12000238 12001058 12017294 12033555 12036413 12067309 12070913 12082058 12083306 12086237 12090369 12105453 12108657 12110531 12125572 12131256 12132690 12141283 12141424 12155213 12155470 12160040 12161209 12164029 12183457 12186933 12187088 12190264 12196946 12201088 12217880 12220986 12224963 12228179 12229650 12232155 12233566 12234040 12236724 12243605 12248412 12251722 12253571 12262233 12266386 12274285 12299880 12310295 12311332 12315456 12332393 12340662 12343184 12351555 12353153 12355764 12357518 12359391 12366246 12367506 12371527 12384931 12392116 12393931 12395275 12401290 12422392 12443899 12447623 12457607 12463314 12492570 12510368 12512594 12516809 12518973 12530906 12546387 12548326 12552886 12562588 12566844 12568154 12573314 12585649 12588803 12591982 12601924 12605701 12613136 12613556 12615503 12617361 12642799 12675523 12686268 12693937 12723557 12870849 12878017 12885918 12889226 12897317 12898258 12908632 12912758 12916654 12917193 12927770 12931440 12932852 12953533 12953686
• 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 = ESW and Original Applicant = BOSTON SCIENTIFIC CORP.