Events

Safety Alert for MiniMed Infusion Set Market Collection

According to National Authority of Drugs and Health Products (Infarmed, Portugal), this safety alert involved a device in Portugal that was produced by Medtronic.

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
    Safety alert
  • Date
    2017-10-02
  • Event Country
    Portugal
  • Event Source
    NADHPIP
  • Event Source URL
    http://www.infarmed.pt/web/infarmed/alertas/-/journal_content/56/15786/2284247
  • Notes / Alerts
    Portuguese data is current through October 2018. All of the data comes from the National Authority of Drugs and Health Products (Infarmed, Portugal), 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 Portugal.
  • Extra notes in the data
  • Action
    Medtronic's MiniMed Infusion Set Market Recall

Device

MiniMed Infusion Set Market Collection

Manufacturer

Medtronic
  • 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
    NADHPIP