Events

Recall of Peripheral stent Pulsar-18 with delivery system

According to Federal Service for Surveillance in Healthcare, this recall involved a device in Russian Federation 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
    01И-1129/15, ФСЗ 2011/10641
  • Date
    2015-07-10
  • Event Date Posted
    2015-07-22
  • Event Country
    Russian Federation
  • Event Source
    FSSH
  • Event Source URL
    http://www.roszdravnadzor.ru/services/unreg
  • Notes / Alerts
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • Extra notes in the data
    Manufacturer Recall

Device

Peripheral stent Pulsar-18 with delivery system

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
    FSSH