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Terminated

Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm Catalog Number: LXB08060

FDA Recall Z-1577-05 · Posted 2005-09-24

Recalling FirmAngiomed Gmbh
Recall StatusTerminated
Product CodeFGE
Date Initiated2005-07-28
Date Terminated2006-05-02
Product Quantity204

Reason for Recall

Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.

Firm Action

On 7/26/05, Angiomed notified by telephone and follow-up letter Conmed Endoscopic Technologies, Billerica, MA [ the US distributor of the Bard Luminexx Endoscopic Biliary Stent ]. ConMed has issued recall notification letters dated 7/28/05 to the US customers of this recall.

Root Cause

Other

Distribution Pattern

Natiowide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031186LUMINEXX ENDOSCOPIC BILIARY STENTC.R. Bard, Inc. · 2003-05-06

Official Source

View FDA Recall →

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

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