Events

Recall Or Safety Alert for IntraStent Unmounted Balloon Expandable Stent

According to Ministry of Health Malaysia, this recall or safety alert involved a device in Malaysia that was produced by ev3 Limited.

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
    MDB/R/2008/005
  • Date
    2008-05-06
  • Event Country
    Malaysia
  • Event Source
    MHM
  • Event Source URL
    https://portal.mda.gov.my/
  • Notes / Alerts
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Extra notes in the data
    MDB/R/2008/005 - IntraStent Unmounted Balloon Expandable Stent.  The manufacturer has advised the Irish Medicines Board of a recall of specific lots of the IntraSrent Unmounted Balloon Expandable Stent.Read more.

Device

IntraStent Unmounted Balloon Expandable Stent

Manufacturer

ev3 Limited
  • 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
    MHM