FDA Medical Device Recalls (openFDA)
Angiomed Gmbh: Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 80 mm Catalog Number: LXB08080
- Recall number
- Z-1578-05
- Recalling firm
- Angiomed Gmbh
- Product
- Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 80 mm Catalog Number: LXB08080
- Status
- Terminated
- Initiated
- 2005-07-28
- Posted
- 2005-09-24
- Terminated
- 2006-05-02
- Reason
- Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.
- 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
- 204 units
- Distribution
- Natiowide
- Lot, serial or model codes
- Lot Number : 96CP1385
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3002806368
- Firm city
- Karlsruhe
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28