Events

Recall of Bile Stent Bard® LUMINEXX® 3;Vascular Stent Bard® LUMINEXX® 3

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by BARD France.

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
  • Date
    2005-08-01
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-dm-stents-bard-r-luminexx-r-3-bard-france-sas
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    The company BARD France SAS has withdrawn from the market on July 26, 2005, the batches and references listed in the appendix (26/07/2005) (34 ko) of the medical devices called Bile Stent Bard® LUMINEXX® 3 and Vascular Stent Bard® LUMINEXX® 3 .. This decision follows modifications made during the manufacturing process of the stents that could cause a malfunction of the devices .. The company has directly notified the recipients of the incriminated lot with the attached message ( 01/08/2005) (16 KB) validated by the Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European competent authorities are informed of this measure by the manufacturer.

Device

Bile Stent Bard® LUMINEXX® 3;Vascular Stent Bard® LUMINEXX® 3
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BARD France

Manufacturer

BARD France