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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 Systemsee related information
Date Initiated by FirmMay 17, 2010
Date PostedJune 25, 2010
Recall Status1 Terminated 3 on October 20, 2011
Recall NumberZ-1859-2010
Recall Event ID 55784
510(K)NumberK032930 
Product Classification Prosthesis, esophageal - Product Code ESW
ProductUltraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/10. Catalog Number M00513710. 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: 11724999 11750562 11772144 11789124 11804527 11805916 11814267 11828772 11838215 11842853 11869860 11871017 11890226 11895585 11910600 11938641 11946094 11960111 11991499 12010105 12106264 12112949 12124527 12167829 12201387 12238992 12249808 12271795 12304585 12319567 12354941 12439846 12464020 12480567 12510365 12547605 12581227 12604481 12686690 12745544 12860643 12885056 12900596 12915092 12932252  
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contactsame
508-683-8000
Manufacturer Reason
for Recall		Suture related device failures during deployment and repositioning of the stent
FDA Determined
Cause 2		Device Design
ActionBoston 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.
DistributionWorldwide Distribution - Only US distributed product is affected by recall
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = ESW
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