Events

Recall of Prostheses HEV and NES

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 Life Partners Europe.

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
    2007-08-08
  • 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-protheses-oesophagiennes-references-hev-et-nes-societe-life-partners-europe
  • 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
    In agreement with Afssaps, the company Life Partners Europe informed, on July 30, 2007, the users of esophageal prostheses HEV and NES, the recall of two batches of prostheses, manufactured in September and December 2006, because of a defect on the thickness of the silicone covering these prostheses. The health institutions concerned by the recall received the enclosed letter (30/07/2007) (18 KB) to the attention of the directors of health establishments, pharmacists and local correspondents of materiovigilance for dissemination to the services concerned. The other European Competent Authorities have been informed of this measure by the manufacturer through his distributors.

Device

Prostheses HEV and NES

Manufacturer

Life Partners Europe