Events

Rappel de Insignia, Contak Renewal TR2 and Vitality 2 models

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par Guidant.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2006-08-07
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • 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    GUIDANT has withdrawn from the market on July 3, 2006 certain implantable cardiac stimulators and defibrillators of Insignia, Contak Renewal TR2 and Vitality 2 models following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
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM