Bard Peripheral Vascular Inc Bard Luminexx 3 Biliary Stent and Delivery System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bard Luminexx 3 Biliary Stent and Delivery System
Brand
Bard Peripheral Vascular Inc
Lot Codes / Batch Numbers
Catalog # Lot # LUB06040 96DP1000, LUB06060 96CP1044 & 96DP2404, LUB14040 96CP2110, LUB14060 96CP0771, 96CP2307, & 96CP2771, LUB14080 96DP2900, LUC05060 96DP2937, LUC06060 96CP2111 & 96DP2939, LUC08040 96CP2310 & 96DP2321
Products Sold
Catalog # Lot # LUB06040 96DP1000; LUB06060 96CP1044 & 96DP2404; LUB14040 96CP2110; LUB14060 96CP0771, 96CP2307, & 96CP2771; LUB14080 96DP2900; LUC05060 96DP2937; LUC06060 96CP2111 & 96DP2939; LUC08040 96CP2310 & 96DP2321
Bard Peripheral Vascular Inc is recalling Bard Luminexx 3 Biliary Stent and Delivery System due to Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Recall notification letter dated July 21, 2005, was sent to Hospital and Physician consignees.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026