Events

Recall of Coroflex Blue coronary stent

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 B.Braun 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
    2005-04-19
  • 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-de-stents-coronaires-coroflex-blue-de-la-societe-b-braun-medical
  • 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
    B.BRAUN Medical withdrew from the market on April 15, 2005 the references and batches specified in the annex, of the medical device called Coroflex Blue coronary stent following two reports concerning a too slow deflation of the balloon .. The company warned directly the recipients (in limited number) of the incriminated lots (15/04/2005) (6 ko) with the attached message (15/04/2005) (9 ko) validated by Afssaps .. This information s address to the directors of health establishments, pharmacists and local correspondents of materiovigilance for dissemination, where appropriate to the departments concerned .. The competent German authority has been informed of this measure by the manufacturer .. Customer mail (15 / 04/2005) (9 KB List of lots concerned (15/04/2005) (6 KB)

Device

Coroflex Blue coronary stent
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B.Braun Medical

Manufacturer

B.Braun Medical