Events

Recall of Celsius Thermocool catheters;Navistar Thermocool catheters

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 BIOSENSE WEBSTER.

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
    2005-08-12
  • 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-d-ablation-de-la-societe-biosense-webster
  • 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    The company BIOSENSE WEBSTER has withdrawn from the market on 10/08/05 batches 13027030 to 13044734 of the medical device called ablation catheters Celsius Thermocool and batches 13027030 to 13044642 of the medical device called ablation catheters Navistar Thermocool following the implementation evidence of an insufficient amount of polyurethane in some catheters that would cause variations in irrigation flow (cases of leakage or occlusion of irrigation fluid have been described). The company has directly notified the recipients of the incriminated lots with the attached message (10/08/2005) (32 KB) validated by Afssaps. This information is addressed to the directors of health facilities and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The competent European authorities concerned are informed of this measure by BIOSENSE WEBSTER.

Device

Celsius Thermocool catheters;Navistar Thermocool catheters
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BIOSENSE WEBSTER

Manufacturer

BIOSENSE WEBSTER