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Terminated

Bard Luminexx 3 Biliary Stent and Delivery System

FDA Recall Z-1585-05 · Posted 2005-09-24

Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2005-07-21
Date Terminated2008-10-23
Product Quantity102

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033497BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEMC.R. Bard, Inc. · 2004-02-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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