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FDA Medical Device Recalls (openFDA)

Angiomed Gmbh: Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x100 mm Catalog Number: LXB10100

Recall number
Z-1583-05
Recalling firm
Angiomed Gmbh
Product
Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x100 mm Catalog Number: LXB10100
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 : 96CP2508
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

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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

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