Recall Z-2327-2010 ยท JCT Prosthesis, Tracheal, Expandable
Boston Scientific Corporation
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (14/4/2.5) Material/UPN/Catalog Number: M00564800
| Date | Aug 31, 2010 (initiated Jul 15, 2010) |
| Status | Terminated |
| Reason | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
| Root cause | Process control |
| Action | Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientifi |
| Quantity | 10 units |
| Distribution | Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden |
| 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 |