Events

Recall of HANAROSTENT Biliary Stent

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 MITech Co., Ltd.

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
    2008-04-25
  • 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-du-dispositif-stent-biliaire-hanarostent-avec-introducteur-de-diametre-7-f-societe-life-partners-europe
  • 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
    On 24/04/08, Life Partners Europe has withdrawn from the market the batches of the references contained in the enclosed message of the medical device known as HANAROSTENT Biliary Stent with Introducer of 7 F diameter manufactured by MITech Co., Ltd., following two incidents in Asia in which the external catheter broke off the introducer during the procedure. Such an incident is patient-free because it appears in the 1st stage of the procedure, before implantation of the prosthesis when the device can be totally removed from the endoscope. Life Partners Europe has directly notified the recipients of the offending lots by means of the attached message (25/04/2008) (37 KB) validated by Afssaps. This information is addressed to the directors, correspondents of materiovigilance and pharmacists for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

HANAROSTENT Biliary Stent
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    MITech Co., Ltd

Manufacturer

MITech Co., Ltd
  • Source
    LAANSM