—#92014

Product

Ultraflex Esophageal Stent System. Covered - Large - Proximal Release - 23/28/12/9. Catalog Number M00514250. 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.

FDA product code: ESW — Prosthesis, Esophageal
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K032930
Affected lot / code info: Lot Numbers: 11719045 11724984 11730519 11739735 11758860 11766259 11774495 11777143 11795313 11795315 11795747 11795763 11796008 11801027 11801490 11802516 11803656 11820724 11821974 11842687 11844355 11844358 11846564 11846567 11859311 11870370 11870914 11879533 11881728 11881733 11896058 11898224 11912084 11912087 11939279 11939387 11941468 11943227 11943231 11944923 11946808 11950577 11950579 11957955 11957956 11959226 11959229 11959854 11962714 11962715 11966089 11966095 11976134 11976136 11980941 11980948 11984100 11985490 11986052 11993327 11994703 12000431 12012604 12013638 12018783 12018793 12025261 12027612 12027618 12031725 12031735 12069097 12069098 12070679 12070760 12080426 12091026 12092333 12110014 12110472 12112183 12121139 12121211 12124535 12125531 12126010 12129557 12129558 12130322 12130613 12130615 12130919 12167505 12167509 12175379 12190056 12194142 12196631 12202053 12202058 12217038 12217074 12224497 12224498 12224808 12225780 12229300 12232510 12232513 12239805 12239811 12241299 12241500 12265999 12266244 12269166 12277042 12298771 12299625 12299626 12304008 12321580 12331558 12341876 12360093 12368636 12384937 12395288 12413526 12444004 12457796 12464955 12496904 12513232 12515792 12517009 12517326 12526858 12530160 12609036 12744766 12774480 12783325 12844409 12849086 12854719 12865029 12879551 12885635 12887673 12899623 12914805 12954056

Why it was recalled

Suture related device failures during deployment and repositioning of the stent

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide Distribution - Only US distributed product is affected by recall

Timeline

Recall initiated: 2010-05-17
Posted by FDA: 2010-06-25
Terminated: 2011-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.