Events

Recall of FIRE START AND DURA START RX PTCA

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 Cordis Europa NV.

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
    2008-01-18
  • 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-catheters-de-dilatation-coronaires-fire-start-et-dura-start-rx-ptca-societe-cordis-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
    On 17/01/08, Cordis SAS withdrew from the market the batches of the references contained in the attached message of the medical device called Coronary Expansion Catheters FIRE START AND DURA START RX PTCA, manufactured by Cordis Europa NV, following claims mentioning an increase in deflation time or an absence of balloon deflation. The company Cordis SAS has directly notified the recipients of the incriminated lots with the message attached (17/01/2008) (37 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

FIRE START AND DURA START RX PTCA
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Cordis Europa NV

Manufacturer

Cordis Europa NV