Bard Luminexx 3 Biliary Stent and Delivery System
FDA device recall Z-1585-05 · posted 2005-09-24 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- Reason for recall
- 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.
- Action taken
- Recall notification letter dated July 21, 2005, was sent to Hospital and Physician consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 102
- Distribution
- Nationwide
- Date initiated
- 2005-07-21
- Date posted
- 2005-09-24
- Date terminated
- 2008-10-23
- Location
- Tempe, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM (K033497) | C.R. Bard, Inc. | 2004-02-04 |