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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-1865-2010
Recall Event ID 55784
510(K)Number K032930  
Product Classification Prosthesis, esophageal - Product Code ESW
Product Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/10. Catalog Number M00513810. 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: 11720486 11741834 11750686 11788787 11804318 11814051 11824077 11846108 11870368 11870594 11909641 11931304 11974372 11982929 12001740 12019957 12074676 12157485 12176238 12184464 12229977 12240225 12297673 12305981 12406877 12464947 12536118 12571835 12882958 12914130 12931878  
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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