Events

Safety Alert for Coronary Angioplasty Guide, model: Galeo.

According to Health Ministry of Cuba, this safety alert involved a device in Cuba that was produced by Biotronik.

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
  • Event Country
    Cuba
  • Event Source
    HMC
  • Event Source URL
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notes / Alerts
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, 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 Cuba.
  • Extra notes in the data

Device

Coronary Angioplasty Guide, model: Galeo.
  • Model / Serial
  • Product Description
    Coronary Angioplasty Guide
  • Manufacturer
    Biotronik

Manufacturer

Biotronik
  • Manufacturer Parent Company (2017)
    Ms Holding Ii Se
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    HMC