Events

Recall of Inflation 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 DE ROYAL.

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
    2006-11-02
  • 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-d-un-systeme-d-inflation-de-la-societe-de-royal
  • 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 DE ROYAL removed from the market on October 27, 2006 lot 66645DR of the medical device called "inflation system" reference 12-003704 following a risk of blockage of the pressure gauge needle contained in this device, which would then cause a erroneous display of pressure and a risk of injuring the vessel by bursting the balloon. This system is used to inflate the balloon of an angioplasty catheter. The distributor has directly notified the recipients of the incriminated lot with the enclosed message (27/10/2006) (19 KB) validated by the This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The European competent authorities concerned are informed of this measure by Afssaps.

Device

Inflation system
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    DE ROYAL

Manufacturer

DE ROYAL
  • Source
    LAANSM