Date Initiated by Firm |
May 17, 2010 |
Date Posted |
June 25, 2010 |
Recall Status1 |
Terminated 3 on October 20, 2011 |
Recall Number |
Z-1848-2010 |
Recall Event ID |
55784 |
510(K)Number |
K012883
|
Product Classification |
Prosthesis, tracheal, expandable - Product Code JCT
|
Product |
Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog Number: M00569530. 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: 9795348 9795351 11072288 11145414 11145416 11206284 11206295 11502622 11627566 11715171 11775940 11794241 11794243 11967261 11967263 12108333 12109170 12180191 12180721 12242449 12242450 12391764 12501651 12624797 12827512 12917370 13022711 13097248 13220248 |
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.
|