Events

Recall of PTCA catheter batches

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.

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
    2004-07-16
  • 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-ptca-de-la-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
    In agreement with Afssaps, CORDIS withdraws from the market the references and batches specified in the attached list (16/07/2004) (44 KB) of the medical device known as "dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA)". AQUA T3 "following the identification of certain catheters that do not have a sufficient internal coating on the body of the extruded tubing, which may cause difficulties during the procedure, such as difficulty in removing the stylet, moving the guide or loosening pressure. No reports have been reported in France to date. The health facilities concerned by this recall are notified directly by CORDIS SAS by means of the attached message (16/07/2004) (40 KB).

Device

PTCA catheter batches
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    CORDIS

Manufacturer

CORDIS