Events

Recall of Cardiovascular stents

According to Korean Food & Drug Administration, this recall involved a device in South Korea that was produced by Biotronic Korea Co., Ltd..

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
    321
  • Date
    2015-07-07
  • Event Country
    South Korea
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, 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 South Korea.
  • Extra notes in the data
    No. 13-1048

Device

Cardiovascular stents

Manufacturer

Biotronic Korea Co., Ltd.
  • Manufacturer Address
    344 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do
  • 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
    KFDA