Z-1585-05

Bard Luminexx 3 Biliary Stent and Delivery System

Name: Z-1585-05 Bard Luminexx 3 Biliary Stent and Delivery System
Creator: Bard Peripheral Vascular Inc
Published: 2005-07-21
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2005-07-21 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Luminexx 3 Biliary Stent and Delivery System on 2005-07-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1585-05
Status: Terminated
Initiated: 2005-07-21
Posted: 2005-09-24
Terminated: 2008-10-23
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard Luminexx 3 Biliary Stent and Delivery System
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recall notification letter dated July 21, 2005, was sent to Hospital and Physician consignees.
Quantity in commerce: 102
Distribution: Nationwide
Product codes and lots: Catalog # Lot # LUB06040 96DP1000; LUB06060 96CP1044 & 96DP2404; LUB14040 96CP2110; LUB14060 96CP0771, 96CP2307, & 96CP2771; LUB14080 96DP2900; LUC05060 96DP2937; LUC06060 96CP2111 & 96DP2939; LUC08040 96CP2310 & 96DP2321

Product code FGE

K033497Class IIBard Luminexx 3 Biliary Stent and Delivery SystemC.R. Bard, Inc. / cleared 2004-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)