Events

Rappel de Pulsar-18 and Pulsar-35 Peripheral Stent System

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par BIOTRONIK AG.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    201506237
  • Date
    2015-06-05
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/systeme-d-endoprothese-peripherique-pulsar-18-et-pulsar-35-biotronik-rappel-de-lots
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    ANSM has been informed of the implementation of a lot withdrawal carried out by BIOTRONIK AG. The users concerned received the attached mail (05/06/2015) (51 KB). This safety action is registered with the ANSM under the number 201506237. You will be able to consult its progress on the Directory of the reports of materialovigilanc. by entering this registration number.

Device

Pulsar-18 and Pulsar-35 Peripheral Stent System
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    BIOTRONIK AG

Manufacturer

BIOTRONIK AG
  • Société-mère du fabricant (2017)
    Ms Holding Ii Se
  • Commentaire du fabricant
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    LAANSM