Events

Recall of Cryolife O'Brien

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 Cryolife.

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
    2010-02-19
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/arret-de-commercialisation-des-valves-aortiques-sans-stent-cryolife-o-brien-par-la-societe-cryolife
  • 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
    In agreement with Afssaps, the manufacturer Cryolife informed on 17/02/10 the users of Cryolife O'Brien aortic valves of the discontinuation of this device and the recall of products in stock, following several incidents of materiovigilance and the results of the survey (18/11/2009) (233 ko) conducted by Afssaps. The users concerned in France have received the attached letter (19/02/2010) (12 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.

Device

Cryolife O'Brien
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Cryolife

Manufacturer

Cryolife