Date Initiated by Firm | May 17, 2010 |
Date Posted | June 25, 2010 |
Recall Status1 |
Terminated 3 on October 20, 2011 |
Recall Number | Z-1822-2010 |
Recall Event ID |
55784 |
510(K)Number | K012883 |
Product Classification |
Prosthesis, tracheal, expandable - Product Code JCT
|
Product | Ultraflex Tracheobronchial Stent System. Uncovered - 12/40 Catalog Number: M00568970. 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: 9664693 9666853 9695256 9698132 9739398 11000897 11000980 11054466 11054467 11062673 11062675 11114765 11150891 11150896 11162419 11162500 11184613 11184618 11202587 11202588 11224039 11224064 11440573 11440575 11496518 11496519 11537476 11582518 11582519 11611462 11611463 11648741 11648746 11677545 11677547 11686362 11735097 11756197 11756872 11773064 11773065 11792820 11792827 11824406 11824407 11864997 11864998 11870587 11870588 11876728 11926873 11926874 12010500 12010501 12012711 12069086 12069087 12080433 12094484 12094485 12218376 12218379 12221872 12222047 12277621 12277625 12403510 12413928 12514613 12562220 12608808 12622580 12691428 12836476 12907151 12918367 12921603 13097256 13106258 13136404 13138517 13229828 13233112 13233284 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JCT
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