Events

Recall Or Safety Alert for CARTOSOUND® module of the CARTO® 3 EP navigation system, catalog number C3SOUND, combined with SOUNDSTAR® 8F and 10F ultrasound catheters, with catalog number 10439236, 10439072, 10439011 and 10438577

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Biosense Webster.

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
  • Date
    2015-10-29
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Safety warning related to the navigation systems CARTO® 3 EP, manufactured by Biosense Webster, Israel, when the intracardiac ultrasound images disappear if the power supply to the system is interrupted.

Device

CARTOSOUND® module of the CARTO® 3 EP navigation system, catalog number C3SOUND, combined with SO...

Manufacturer

Biosense Webster