Events

Recall of Insignia, Contak Renewal TR2 and Vitality 2 models

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 Guidant.

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
    2006-08-07
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/informations-complementaires-au-retrait-des-stimulateurs-et-defibrillateurs-cardiaques-implantables-de-la-societe-guidant
  • 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
    GUIDANT has withdrawn from the market on July 3, 2006 certain implantable cardiac stimulators and defibrillators of Insignia, Contak Renewal TR2 and Vitality 2 models following recent incidents that revealed the failure of a low-voltage capacitor, leading to a risk of malfunction of these devices. . This withdrawal was accompanied by recommendations for monitoring implanted patients. The company has directly notified the physicians who follow up patients with these devices, using the attached message. validated by Afssaps. Afssaps was informed that the company Guidant had published on August 2, 2006 an update of this information (03/08/2006) (37 KB) stating that other serial numbers were affected by the information broadcast on July 3. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The European competent authorities concerned are informed of this measure by the manufacturer.

Device

Insignia, Contak Renewal TR2 and Vitality 2 models
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM