Bard Luminexx Endoscopic Biliary Stent and Delivery System… recallZ-1577-05 · Angiomed Gmbh · initiated Jul 28, 2005
Terminated All recalls posted in September 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiomed Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1577-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 28, 2005
- Posted by the FDA
- Sep 24, 2005
- Recalling firm
- Angiomed Gmbh
- Quantity
- 204
- Product code
- FGE
- FDA submissions
- K031186
- Distribution
- Natiowide
Product description
Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm Catalog Number: LXB08060
Code information (models, lots, serial numbers)
Lot Number: 96CP1992
Other devices under the same FDA submission
2 devices cleared under K031186 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Flexxus® Endoscopic Biliary Stent LXB10080Angiomed GmbH & Co. Medizintechnik KG · CATHETER, BILIARY, DIAGNOSTIC5 reports
- Flexxus® Endoscopic Biliary Stent LXB08100Angiomed GmbH & Co. Medizintechnik KG · CATHETER, BILIARY, DIAGNOSTIC1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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