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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraflex Esophageal Stent System

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  Class 2 Device Recall Ultraflex Esophageal 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-1868-2010
Recall Event ID 55784
510(K)Number K032930  
Product Classification Prosthesis, esophageal - Product Code ESW
Product Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/12/9. Catalog Number M00513850. 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 Numbers: 11716747 11719459 11721821 11729926 11729998 11731974 11731983 11734667 117401681 11748529 11748768 11752059 11757914 11766370 11767173 11770846 11776069 11777140 11781775 11784015 11787078 11793310 11794248 11799820 11801118 11802514 11803110 11809195 11810170 11811464 11820413 11821001 11822969 11826373 11831892 11838256 11838878 11839736 11844020 11846185 11846248 11846253 11846951 11846953 11858576 11861902 11863820 11871706 11875454 11876887 11880510 11883101 11891860 11892090 11893164 11898231 11898232 11905969 11909657 11913442 11926201 11926876 11930247 11930248 11940106 11942632 11945163 11947855 11947856 11958960 11958965 11960293 11960789 11966833 11967086 11974373 11980938 11983599 11985454 11991968 11994271 11994745 11995508 11997279 12000316 12002171 12020711 12028205 12031085 12036202 12071753 12081195 12088720 12090373 12103455 12104002 12113175 12120857 12125768 12126304 12130611 12132860 12143419 12167827 12170973 12174452 12177448 12181376 12183455 12185865 12199514 12202572 12204721 12205766 12206478 12215868 12217072 12221748 12222787 12224170 12224983 12226310 12230469 12236287 12241937 12242446 12247537 12256681 12260344 12261778 12270641 12277629 12277716 12284878 12286552 12292490 12294566 12295525 12298435 12298619 12299291 12303231 12317109 12322291 12322876 12336666 12339193 12350706 12356418 12358035 12359808 12369556 12373110 12374928 12375936 12377238 12378467 12391988 12402898 12411192 12448650 12458095 12464951 12468986 12469409 12493640 12495520 12504814 12513458 12521091 12530616 12535032 12535250 12545690 12551951 12553334 12562537 12566799 12577393 12579867 12589363 12590909 12650905 12650919 12651073 12651493 12651739 12658453 12671016 12676815 12690802 12696732 12722747 12723422 12752297 12754746 12758346 12759743 12763271 12771600 12837116 12853231 12859758 12861354 12864736 12867422 12869971 12872081 12878780 12880787 12891195 12895995 12899912 12914733 12920992 129280381 129318721  
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 = ESW and Original Applicant = BOSTON SCIENTIFIC CORP.
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