Events

Recall of DOLPHIN 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 SEDAT.

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-dolphin-de-la-societe-sedat
  • 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    The SEDAT company has withdrawn from the market on October 27, 2006, the batches of the references specified in the annex of the medical device called "DOLPHIN inflation system" following a risk of blockage of the pressure gauge needle contained in this device, which would then cause a incorrect display of pressure. This system is used to inflate the balloon of an angioplasty catheter. The manufacturer has directly notified the recipients of the incriminated batches with the enclosed message (27/10/2006) (56 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

DOLPHIN inflation system
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SEDAT

Manufacturer

SEDAT
  • Source
    LAANSM