Events

Recall of Carotid silicone carotid balloon

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 Edwards Lifesciences.

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
    2006-07-11
  • 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-lot-de-shunt-carotidien-silicone-a-ballonnet-de-la-societe-edwards-lifesciences
  • 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    The company Edwards Lifesciences has withdrawn from the market on July 07, 2006 lot 58220388 of the medical device called carotid silicone carotid balloon reference T3103AS following an error of presentation of the device compared to the reference product (the product may contain a control valve instead a faucet on the inflating line of the balloon) .. The company has directly notified the recipients of the offending lot with the message attached (07/07/2006) (23 KB) validated by 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

Carotid silicone carotid balloon

Manufacturer

Edwards Lifesciences