Events

Recall of BioMatrix Flex ™ and BioMatrix NeoFlex ™ Active Elution Coronary Stent (DES) Systems

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 BIOSENSORS.

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
    201603164
  • Date
    2016-03-14
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/systemes-d-endoprothese-coronaire-a-elution-de-principe-actif-des-biomatrix-flex-et-biomatrix-neoflex-information-de-securite
  • 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 batch withdrawal carried out by the company BIOSENSORS .. The users concerned have received the attached mail (14/03/2016) (161 KB). This safety action is registered with the ANSM under the number 201603164. You will be able to consult its progress report on the Directory of the signaling of materiovigilance. by entering this registration number.

Device

BioMatrix Flex ™ and BioMatrix NeoFlex ™ Active Elution Coronary Stent (DES) Systems
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BIOSENSORS

Manufacturer

BIOSENSORS