Safety Alert for Balloon dilatation catheters, Balloon Expandable Stents, Self-Expandable Nitinol Stent.

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

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
    2018-07-16
  • Event Country
  • Event Source
    NADHPIP
  • Event Source URL
  • 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
    CE Certificate of False Compliance - Manufacturer Pan Medical US Corp. Ltd.

Manufacturer