Events

Rappel de AMPLATZER Occluder for Arterial Canal Closure

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 AGA MEDICAL.

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
    2005-09-14
  • 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/retrait-de-lots-d-occludeur-amplatzer-pour-fermeture-de-canal-arteriel-aga-medical-corp
  • 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
    The Afssaps was informed on September 9, 2005 by the company MED-IMPULSE, of a withdrawal of the market on September 8, 2005, all lots of references 9-PDA-004 to 9-PDA-009 of the medical device called " AMPLATZER Occluder for Arterial Canal Closure "manufactured by AGA Medical Corporation. This recall follows the presence of a roughness that could scrape the inner layer of polytetrafluoroethylene sheath implementation during its transfer and generate micro-particles that can be carried in the blood. The company has directly notified the recipients concerned with the message attached (09/09/2005) (28 KB). This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

AMPLATZER Occluder for Arterial Canal Closure
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    AGA MEDICAL

Manufacturer

AGA MEDICAL
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    LAANSM