Events

Recall of Ordering System

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
  • Event ID
    201501845
  • Date
    2015-08-28
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/systeme-de-mise-en-place-commander-societe-edwards-rappel
  • 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 ANSM has been informed of the implementation of a withdrawal of product by the company EDWARDS LIFESCIENCES LLC .. The users concerned have received the attached mail (28/08/2015) (422 KB). This recall follows two previous security information, released in February and June 2015. This security action is registered with the ANSM under the number 201501845. You will be able to consult its progress on the Directory of materiovigilance reports by entering this number. Read too. Commander - Edwards Implementation System - Security Information of 25/02/201. Commander - Edwards Implementation System - Safety Information from 16/06/2015

Device

Ordering System

Manufacturer

Edwards Lifesciences