Recall Z-1851-2010
Boston Scientific Corporation · initiated May 17, 2010
Product
Ultraflex Tracheobronchial Stent System. Covered - 18/80/65 Catalog Number: M00569560. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
Codes / lots: Lot Numbers: 9816069 9817313 11036675 11036678 11144629 11144633 11166987 11166989 11216390 11216391 11323985 11396170 11445664 11482673 11482674 11573664 11587624 11587625 11632696 11632698 11684142 11729256 11729291 11758555 11758559 11800671 11857948 11857950 11864916 11864981 11924090 11924160 11981528 12063950 12063951 12095744 12189616 12219705 12219708 12222329 12300932 12300934 12323321 12372682 12422996 12493176 12533397 12607272 12616628 12672122 12723732 12852679 12951197 12974865 13125446 13191733 13197059
Reason for recall
Suture related device failures during deployment and repositioning of the stent
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1851-2010
- Initiated
- May 17, 2010
- Posted by FDA
- June 25, 2010
- Terminated
- October 20, 2011
- Product code
- JCT – Prosthesis, Tracheal, Expandable
- Distribution
- Worldwide Distribution - Only US distributed product is affected by recall
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1817-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog Number: M00568920.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1818-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 8/40 Catalog Number: M00568930.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1819-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 10/20 Catalog Number: M00568940.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1820-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 10/40 Catalog Number: M00568950.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1821-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 12/20 Catalog Number: M00568960.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1822-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 12/40 Catalog Number: M00568970.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1823-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1824-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 14/80 Catalog Number: M00569000.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1825-2010 | Ultraflex Tracheobronchial Stent System. Covered - 14/30/15 Catalog Number: M00569040.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1826-2010 | Ultraflex Tracheobronchial Stent System. Covered - 10/30/15 Catalog Number: M00569050.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1827-2010 | Ultraflex Tracheobronchial Stent System. Covered - 12/30/15 Catalog Number: M00569060.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1828-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 10/30 Catalog Number: M00569070.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1829-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog Number: M00569080.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1830-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog Number: M00569090.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1831-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 16/40 Catalog Number: M00569230.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1832-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 16/60 Catalog Number: M00569240.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1833-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 16/80 Catalog Number: M00569250.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1834-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1835-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1836-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 18/80 Catalog Number: M00569280.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1837-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog Number: M00569290.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1838-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1839-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1840-2010 | Ultraflex Tracheobronchial Stent System. Covered - 8/40/25 Catalog Number: M00569410.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1841-2010 | Ultraflex Tracheobronchial Stent System. Covered - 10/40/25 Catalog Number: M00569430.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1842-2010 | Ultraflex Tracheobronchial Stent System. Covered - 12/40/25 Catalog Number: M00569450.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1843-2010 | Ultraflex Tracheobronchial Stent System. Covered - 14/40/25 Catalog Number: M00569480.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1844-2010 | Ultraflex Tracheobronchial Stent System. Covered - 14/60/45 Catalog Number: M00569490.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1845-2010 | Ultraflex Tracheobronchial Stent System. Covered - 18/40/65 Catalog Number: M00569500.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |
| Z-1846-2010 | Ultraflex Tracheobronchial Stent System. Covered - 16/40/25 Catalog Number: M00569510.…Suture related device failures during deployment and repositioning of the stent | 05/17/2010Terminated |