FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: Bard Luminexx 3 Biliary Stent and Delivery System
- Recall number
- Z-1585-05
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Bard Luminexx 3 Biliary Stent and Delivery System
- Status
- Terminated
- Initiated
- 2005-07-21
- Posted
- 2005-09-24
- Terminated
- 2008-10-23
- 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
- Lot, serial or model codes
- Catalog # Lot # LUB06040 96DP1000; LUB06060 96CP1044 & 96DP2404; LUB14040 96CP2110; LUB14060 96CP0771, 96CP2307, & 96CP2771; LUB14080 96DP2900; LUC05060 96DP2937; LUC06060 96CP2111 & 96DP2939; LUC08040 96CP2310 & 96DP2321
- 510(k) numbers
- ["K033497"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28