Events

Recall of Plastic Aortic Infusion Cannulas

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
    2006-05-11
  • 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-lots-de-canule-de-perfusion-aortique-edwards-lifesciences-sas
  • 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
    Edwards Lifesciences has withdrawn from the market the references and batches specified in the medical device recall message "Plastic Aortic Infusion Cannulas" as a result of claims of breakage at either the fixation eyelets or Distal end level. The company has directly notified the recipients of the incriminated lots with the message attached (11/05/2006) (62 KB) validated by the Afssaps. health facility directors and local correspondents for medical equipment for dissemination, where appropriate to the departments concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

Plastic Aortic Infusion Cannulas

Manufacturer

Edwards Lifesciences