Recall Or Safety Alert for THERMOCOOL SMARTTOUCH® SF unidirectional and bi-directional navigation catheter, THERMOCOOL SMARTTOUCH® unidirectional and bidirectional navigation catheter, THERMOCOOL SMARTTOUCH® SF NAV diagnostic / ablation catheter

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 N/A.

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
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Removal from the market of certain batches of THERMOCOOL catheters due to the possibility of ablating in an unwanted area, when alert 402 "Map: magnetic distortion" appears when they are connected to the CARTO® 3 system, and it is not possible to deactivate it.


  • Source