Events

Recall of AMPLATZER Occluder for Arterial Canal Closure

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 AGA MEDICAL.

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
    2005-09-14
  • 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-d-occludeur-amplatzer-pour-fermeture-de-canal-arteriel-aga-medical-corp
  • 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 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
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    AGA MEDICAL

Manufacturer

AGA MEDICAL
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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