Events

Recall of Guide MicroTherapeutics SilverSpeed

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 ev3.

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
    2007-04-12
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-guides-microtherapeutics-silverspeed--010-ev3
  • 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    The ev3 company has withdrawn from the market on 11/04/07 the lots specified in the appendix, of the medical device called Guide MicroTherapeutics SilverSpeed ​​.010. reference 103-0601-200 following the degradation, on some units of these lots, of the hydrophilic coating. The company has directly notified the recipients of the incriminated lots with the message attached (11/04/2007) (24 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary, to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Guide MicroTherapeutics SilverSpeed
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    ev3

Manufacturer

ev3
  • Source
    LAANSM