Date Initiated by Firm |
May 17, 2010 |
Date Posted |
June 25, 2010 |
Recall Status1 |
Terminated 3 on October 20, 2011 |
Recall Number |
Z-1820-2010 |
Recall Event ID |
55784 |
510(K)Number |
K012883
|
Product Classification |
Prosthesis, tracheal, expandable - Product Code JCT
|
Product |
Ultraflex Tracheobronchial Stent System. Uncovered - 10/40 Catalog Number: M00568950. 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: 9819553 9819558 11057820 11057934 11128481 11128701 11188630 11188633 11254268 11254269 11327810 11327811 11486465 11486466 11591307 11648322 11648324 11687601 11740562 11792533 11828568 11828569 11891601 11933261 11933262 12150199 12295530 12305996 12395349 12463767 12517752 12602517 12619264 12652845 12685511 12687464 12862108 12870991 13074818 13103999 13129113 13138519 13203489 |
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.
|