Z-1582-05

Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 80 mm Catalog Number: LXB10080

Name: Z-1582-05 Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 80 mm Catalog Number: LXB10080
Creator: Angiomed Gmbh
Published: 2005-07-28
License: https://open.fda.gov/license/

Angiomed GmbH & Co. Medizintechnik KG / initiated 2005-07-28 / Terminated

FDA source

Angiomed Gmbh began a recall of Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 80 mm Catalog Number: LXB10080 on 2005-07-28. The reason FDA records is "Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1582-05
Status: Terminated
Initiated: 2005-07-28
Posted: 2005-09-24
Terminated: 2006-05-02
Recalling firm: Angiomed GmbH & Co. Medizintechnik KG
Product: Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 80 mm Catalog Number: LXB10080
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.
FDA root cause: Other
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.
Quantity in commerce: 204 units
Distribution: Natiowide
Product codes and lots: Lot Numbers : 96CP1394, 96CP1395, 96CP1396, 96CP1397, 96CP1995

Product code FGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)