Recall Z-1835-2010 ยท JCT Prosthesis, Tracheal, Expandable
Boston Scientific Corporation
Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
| Date | Jun 25, 2010 (initiated May 17, 2010) |
| Status | Terminated |
| Reason | Suture related device failures during deployment and repositioning of the stent |
| Root cause | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012883 | ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM Boston Scientific Corp, Oct 12, 2001 |