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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraflex tracheobronchial Stent System

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 Class 2 Device Recall Ultraflex tracheobronchial Stent Systemsee related information
Date Initiated by FirmMay 17, 2010
Date PostedJune 25, 2010
Recall Status1 Terminated 3 on October 20, 2011
Recall NumberZ-1839-2010
Recall Event ID 55784
510(K)NumberK012883 
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
ProductUltraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
Code Information Lot Numbers: 9820027 9820415 11092859 11093048 11752551 11962126 11962127 
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 = JCT
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