Date Initiated by Firm |
May 17, 2010 |
Date Posted |
June 25, 2010 |
Recall Status1 |
Terminated 3 on October 20, 2011 |
Recall Number |
Z-1819-2010 |
Recall Event ID |
55784 |
510(K)Number |
K012883
|
Product Classification |
Prosthesis, tracheal, expandable - Product Code JCT
|
Product |
Ultraflex Tracheobronchial Stent System. Uncovered - 10/20 Catalog Number: M00568940. 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: 9816662 9816664 9825225 9825231 11040448 11041182 11078192 11078420 11093973 11093975 11108899 11110944 11162018 11191140 11191143 11318358 11318707 11412065 11412066 11428368 11428370 11522460 11522461 11559400 11559402 11593826 11593832 11626022 11626025 11659418 11659419 11666874 11666875 11682980 11682981 11722921 11722925 11734945 11756575 11756620 11782914 11782919 11792137 11792360 11825611 11825614 11829608 11829612 11846116 11846118 11902527 11903035 11927690 11927691 11943670 11943683 11973645 11973646 12035398 12035641 12051921 12089897 12089898 12122981 12143396 12143721 12197267 12197268 12205131 12205132 12238955 12238956 12274500 12274503 12314919 12318374 12391990 12398060 12404315 12491821 12500427 12536945 12587048 12603447 12606861 12619342 12635155 12675579 12729536 12743685 12771606 12844953 12888561 12906495 12989820 13016857 13064646 13071656 13075798 13103652 13119112 13173450 13188899 13191108 13218308 13221250 13315928 |
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 = JCT and Original Applicant = BOSTON SCIENTIFIC CORP.
|