Events

Recall of Bard¿ Luminexx¿ Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 80 mm || Catalog Number: LXB08080

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiomed Gmbh.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32853
  • Event Risk Class
    Class 2
  • Event Number
    Z-1578-05
  • Event Initiated Date
    2005-07-28
  • Event Date Posted
    2005-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40988
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • Reason
    Biliary stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.
  • 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.

Device

Bard¿ Luminexx¿ Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 80 mm || Catalog N...
  • Model / Serial
    Lot Number : 96CP1385
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Natiowide
  • Product Description
    Bard¿ Luminexx¿ Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 80 mm || Catalog Number: LXB08080
  • Manufacturer
    Angiomed Gmbh

Manufacturer

Angiomed Gmbh
  • Manufacturer Address
    Angiomed Gmbh, Wachhausstrasse 6, Karlsruhe Germany
  • Source
    USFDA