Events

Recall of Auxiliary cardiac device

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

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
    733
  • Date
    2017-10-27
  • 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. 13-3075

Device

Auxiliary cardiac device
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Used for patients at risk of death due to terminal heart failure (left ventricle, right ventricle). It is designed to be discharged after the procedure and to be able to do everyday life.
  • Manufacturer
    Medtronic Korea

Manufacturer

Medtronic Korea
  • Manufacturer Address
    Seoul, Korea 534 Teheran-ro, Gangnam-gu, Seoul
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    KFDA