Recall Z-1585-05 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Bard Peripheral Vascular Inc
Bard Luminexx 3 Biliary Stent and Delivery System
| Date | Sep 24, 2005 (initiated Jul 21, 2005) |
| Status | Terminated |
| Reason | Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause to be a manufacturing change from polymer to aluminum fixtures. |
| Root cause | Other |
| Action | Recall notification letter dated July 21, 2005, was sent to Hospital and Physician consignees. |
| Quantity | 102 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033497 | BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM C.R. Bard, Inc., Feb 4, 2004 |