Events

Recall Or Safety Alert for Biological heart valves with accessories: Mosaic Aortic abdurator

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Medtronic Inc. (Medtronic Heart Valves Division, Medtronic CoreValve, LLC), UNITED STATES OF AMERICA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety alert
  • Event Number
    ИМ-7.97407/1401
  • Date
    2014-03-02
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Extra notes in the data
  • Reason
    Medtronic, inc. has initiated a review of the mosaic aortic abturator (model 7305), due to the higher-than-expected transvalvular gradients occurring after implantation.

Device

Biological heart valves with accessories: Mosaic Aortic abdurator

Manufacturer

Medtronic Inc. (Medtronic Heart Valves Division, Medtronic CoreValve, LLC), UNITED STATES OF AMERICA
  • 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
    MHRB