# K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System - Pathway: 510(k) (Special) - Applicant: Boston Scientific Corp - Decided: Oct 12, 2001 after 45 days - Product code: ESW (Prosthesis, Esophageal) - Device class: 2 - Regulation: 21 CFR 878.3610 - Recalls of this device: 46 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K925406 (1995). 4 ancestors in all. 21 later devices descend from it; 4 cite it directly. 0 of 26 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K940838: Microvasive Ultraflex Esophageal Stent System, Boston Scientific Corp (1994) Summary page 6. - K962899: Ultraflex Diamond, Boston Scientific Corp (1997) Summary page 6. - K963241: Ultraflex, Boston Scientific Corp (1996) ## Most influential descendants - K073266: Wallflex Partially Covered Esophageal Stent System (2008), 15 descendants of its own - K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 (2009), 14 descendants of its own - K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered (2012), 5 descendants of its own - K072094: Choostent (2008), 5 descendants of its own - K180144: Agile Esophageal Stent System (2018), 3 descendants of its own ## Recalls of this device - Jul 15, 2010 · Not classified · Z-2327-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. - Jul 15, 2010 · Not classified · Z-2326-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. - Jul 15, 2010 · Not classified · Z-2325-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. - Jul 15, 2010 · Not classified · Z-2328-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. - Jul 15, 2010 · Not classified · Z-2330-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. - Jul 15, 2010 · Not classified · Z-2329-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. - May 17, 2010 · Not classified · Z-1828-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1843-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1837-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1817-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1848-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1839-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1823-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1836-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1829-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1835-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1821-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1844-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1822-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1830-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1842-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1850-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1833-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1855-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1825-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1849-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1846-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1838-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1847-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1853-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1827-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1852-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1820-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1834-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1819-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1840-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1831-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1845-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1856-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1818-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1854-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1841-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1832-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1826-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1824-2010: Suture related device failures during deployment and repositioning of the stent - May 17, 2010 · Not classified · Z-1851-2010: Suture related device failures during deployment and repositioning of the stent ## Indications for use The Ultraflex Diamond Biliaty Stent is indicated for palliative treatment of patients with malignant biliaty strictures. The Ultraflex Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. The ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms. Source page: https://510kreport.com/device/K012883 Methodology: https://510kreport.com/methodology