Events

Field Safety Notices about Pulsar-18, Peripheral self-expanding Nitinol stent system

According to Health Sciences Authority (HSA), this field safety notices involved a device in Singapore that was produced by Biotronik Asia Pacific Pte Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    600:41/01-269/18/01_37
  • Date
    2018-04-09
  • Event Country
    Singapore
  • Event Source
    HSA
  • Event Source URL
    https://www.hsa.gov.sg/announcements
  • Notes / Alerts
    Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
  • Extra notes in the data
    Biotronik AG

Device

Pulsar-18, Peripheral self-expanding Nitinol stent system
  • Model / Serial
  • Product Description
    Pulsar-18, Peripheral self-expanding Nitinol stent system, Biotronik AG
  • Manufacturer
    Biotronik Asia Pacific Pte Ltd

Manufacturer

Biotronik Asia Pacific Pte Ltd
  • 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
    HSAHSA