Events

Recall of TwinOne Temporary Expansion and Occlusion Catheter

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 Minvasys.

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
  • Event ID
    R1600091
  • Date
    2016-04-05
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/catheter-de-dilatation-et-d-occlusion-temporaire-twinone-minvasys-rappel-de-lot
  • 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 ANSM has been informed of the implementation of a lot withdrawal carried out by the company MINVASYS. The only health establishment concerned in France have received the attached mail (05/04/2016) (18 KB ). This safety action is registered at ANSM under the number R1600091. You will be able to check its progress on the Directory of Materielovigilance Reports. by entering this registration number.

Device

TwinOne Temporary Expansion and Occlusion Catheter
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Minvasys

Manufacturer

Minvasys
  • Source
    LAANSM