Safety Alert for Commercial Name: EP NAVIGATION SYSTEM - CARTO System 3 Technical Name: SURGICAL NAVIGATION SYSTEM ANVISA Registration Number: 80145901192 Hazard Class: III Affected Model: CARTO System 3 Affected serial numbers: SKU FG540000 and FG540000U

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

Some instructions are recommended: 1. Do not ignore system indicators such as significant noise during ablation or an Error 7 message (a leakage current fault available in some configurations of the CARTO® System 3). Follow the Instructions for Use and stop using the system if there is a suspected leak. 2. Do not perform ablation while the impedance readings of the ablation catheter are in extreme values ​​beyond 250 O (or 300 O in the case of the Multichannel RF Generator MARQ®1). Monitor the impedance during the procedure and avoid turning off the Impedance Limit Setting on the radio frequency (RF) generator. [NOTE: If you are performing a procedure with an experimental device in a clinical study, follow the requirements of the approved protocol]. 3. In addition, avoid ablation during pacing with the same electrode of the ablation catheter. 4. Stay aware of this notice and pass it on to everyone at your workplace who needs to be informed and complete, sign, and return the Business Response Form.