Events

Recall of Tsunami Gold coronary stents

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 TERUMO.

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
    2005-12-27
  • 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-d-endoprotheses-coronaires-tsunami-gold-de-la-societe-terumo
  • 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    The company TERUMO France has withdrawn from the market on December 21, 2005 all batches of references specified in the appendix, the medical device called "Tsunami Gold coronary stents" of 4.0 mm in diameter following a few incidents likely related to a defect of deployment of the balloon. No serious cases have been reported to date in France. The company has directly notified the recipients of the references and the incriminated lots by means of the attached message (21/12/2005) (49 KB) validated by Afssaps. This information is addressed to the directors of health establishments, pharmacists 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

Tsunami Gold coronary stents
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    TERUMO

Manufacturer

TERUMO