Events

Recall of Pulsar-18 and Pulsar-35 Peripheral Stent System

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 BIOTRONIK AG.

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
    201506237
  • Date
    2015-06-05
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/systeme-d-endoprothese-peripherique-pulsar-18-et-pulsar-35-biotronik-rappel-de-lots
  • 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
    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
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BIOTRONIK AG

Manufacturer

BIOTRONIK AG
  • Manufacturer Parent Company (2017)
    Ms Holding Ii Se
  • Manufacturer comment
    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