Events

Recall of Peripheral interventional guides 0.018 Cordis (SV-5 and SV-8)

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 SAS.

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
    2006-07-26
  • 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-du-dm-guides-interventionnels-peripheriques-0-018-cordis-societe-cordis
  • 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
    CORDIS SAS has withdrawn from the market on 25/07/2006 the batches indicated in the attached message of the medical device called Peripheral interventional guides 0.018 Cordis (SV-5 and SV-8) following the highlighting of a Possibility of fracture of the extremity, which can lead to a separation of the end of the guide. The company directly warned the recipients of the incriminated batch with the help of the attached message (25/07/2006) (23 ko ) This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The European competent authorities concerned are informed of this measure by the manufacturer. .

Device

Peripheral interventional guides 0.018 Cordis (SV-5 and SV-8)
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    CORDIS SAS

Manufacturer

CORDIS SAS
  • Source
    LAANSM