Events

Rappel de Pulsar-18, Peripheral self-expanding Nitinol stent system

Selon Republic of Lebanon Ministry of Public Health, ce/cet/cette rappel concerne un dispositif en/au/aux/à Lebanon 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
  • Date
    2018-03-26
  • Pays de l'événement
    Lebanon
  • Source de l'événement
    RLMPH
  • URL de la source de l'événement
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202018/26-3-2018/Pulsar18PeripheralselfexpandingNitinolstentsystem.pdf
  • Notes / Alertes
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
  • Notes supplémentaires dans les données

Device

Pulsar-18, Peripheral self-expanding Nitinol stent system

Manufacturer

BIOTRONIK AG
  • 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.
  • Représentant du fabricant
    Benta Trading
  • Source
    RLMPH