Events

Recall of ConMed Linvatec Convertible LightWave Ablators

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 ConMed Linvatec.

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
    2009-08-18
  • 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-des-lots-du-dispositif-medical-ablateurs-lightwave-a-aspiration-conmed-linvatec
  • 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    On 14/08/2009, ConMed Linvatec France has withdrawn from the market all the batches of the reference IA-2000-S mentioned in the appendix of the medical device recall letter called: ConMed Linvatec Convertible LightWave Ablators, manufactured by ConMed Linvatec in the USA. As a result of claims in the United States, ConMed Linvatec has determined the possibility for the medical device to not shut down when releasing the interrupt button. The malfunction may result in injury to the patient or the user. The company ConMed Linvatec France has directly notified the recipients of the offending lots with the enclosed message validated (18/08/2009) (25 KB) by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned have been informed of this measure by ConMed Linvatec.

Device

ConMed Linvatec Convertible LightWave Ablators
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    ConMed Linvatec

Manufacturer

ConMed Linvatec