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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-1871-2010
Recall Event ID 55784
510(K)Number K032930  
Product Classification Prosthesis, esophageal - Product Code ESW
Product Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/12/9. Catalog Number M00514210. 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: 11717711 11724773 11724821 11740949 11740950 11758120 11773829 11773830 11776233 11781153   11823969 11783845 11824410 11784685 11785961   11825268 11841440 11787065 11845370 11789049   11845371 11789057 11859979 11812345 11860149 11823964 11870001 11872198 11872240 11879539 11879701 11909989 11909991 11926787 11928990 11939030 11940208 11942768 11942770 11944927 11944928 11948620 11948621 11964244 11969470   11975135 11975138 11976455 11976458 11978050 11980066 11981134 11981136 11987447 11987449 11991648 11992547 11992548 11993075 11999174 11999301 12012794 12012796 12015068 12015069 12018344 12018346 12020717 12020762 12028625 12028626 12070326 12070331 12086417 12088066 12092750 12092932 12101606 12104901 12108334 12108336 12114110 12141917 12144954 12144957 12148033 12148035 12161936 12167107 12167110   12175221 12175224 12200060 12200870 12202393 12202394 12204539 12215871 12225291 12256259 12270642 12270651 12310934 12312393 12317119 12320759 12336867 12353989 12358206 12378610 12394716 12396146 12412092 12445307 12466351 12495403 12499619 12534929 12549245 12550831 12579546 12583810 12607730 12757227 12759139 12851965 12867689 12877475 12884421 12887318 12901429 12912301 12930193 12950469  
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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