Recalls / —

—#41079

Product

Bard Luminexx 3 Biliary Stent and Delivery System

FDA product code

FGE — Stents, Drains And Dilators For The Biliary Ducts

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K033497

Affected lot / code info

Catalog # Lot # LUB06040 96DP1000; LUB06060 96CP1044 & 96DP2404; LUB14040 96CP2110; LUB14060 96CP0771, 96CP2307, & 96CP2771; LUB14080 96DP2900; LUC05060 96DP2937; LUC06060 96CP2111 & 96DP2939; LUC08040 96CP2310 & 96DP2321

Why it was recalled

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 (FDA determination)

Other

Action the firm took

Recall notification letter dated July 21, 2005, was sent to Hospital and Physician consignees.

Recalling firm

Firm

Bard Peripheral Vascular Inc

Address

1625 W 3rd St, Tempe, Arizona 85281-2438

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2005-07-21

Posted by FDA

2005-09-24

Terminated

2008-10-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41079. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.