Carto 3 CR3434CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835003871), received between Apr 2, 2019 and May 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Transmit Record” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K090017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Overheating of Device; Failure to Transmit Record; Insufficient Device Problem Information; Overheating of Device; Failure to Transmit Record; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A CARTO® 3 SYSTEM INTERFACE CABLE AND BURNT MARKS WERE FOUND ON THE INSIDE PIN AREA. UPON PREPARING EVERYTHING FOR THE DOCTOR TO START THE PROCEDURE, ERROR 101 WAS NOTICED RELATED TO THE ABLATION CATHETER. THE SCRUB TECH WAS ASKED TO DISCONNECT IT AND THE PIU TOO WOULD ALSO BE UNPLUGGED. ONLY WHEN SHE DISCONNECT THE CATHETER FROM ITS CABLE THE SCRUB TECH IDENTIFIED BOTH THE CATHETER AND CONNECTOR HAD A BURNT MARK ON THE INSIDE PINS. BOTH THE CONNECTOR AND THE CATHETER WERE REPLACED. AFTER THAT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO SIGNS OF ANY VISIBLE FILE, FLAME OR SMOKE. IT WAS MORE SO THAT THE CONNECTOR EXPERIENCED A SHORT CIRCUIT OR SOMETHING THAT CAUSED BURN MARKS ON THE PINS WHERE IT JOINS THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287385 ↗
• MalfunctionApr 2, 2019Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM INTERFACE CABLE AND AN ISSUE OF INADVERTENT PACING OCCURRED. IT WAS DESCRIBED THAT THE CARTO® 3 SYSTEM WAS DISPLAYING NOISE ON THE ELECTROCARDIOGRAM (ECG) SIGNALS. IT WAS ALSO REPORTED THE ABLATION CATHETER AND THE CATHETER CONNECTED TO THE 20A PORT WERE DISPLAYING PACING DESPITE NO PACING BEING ACTIVE AND NO PACING CHANNELS BEING OPEN. ALL CABLES WERE DISCONNECTED FROM THE PATIENT INTERFACE UNIT (PIU) AND BOTH THE PATIENT INTERFACE UNIT (PIU) AND WORKSTATION WERE REBOOTED. THE PATIENT INTERFACE UNIT (PIU) BOOTED UP NORMALLY. WHEN THE ABLATION CABLE WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU) ALL ECG SIGNALS WERE LOST, HOWEVER, ONCE DISCONNECTED FROM THE PATIENT INTERFACE UNIT (PIU), THE ECG SIGNAL RETURNED. THE CUSTOMER WAS ADVISED TO REPLACE THE CARTO® 3 SYSTEM INTERFACE CABLE AND THEN THE ISSUES RESOLVED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCE WAS REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE CUSTOMER¿S REPORTED ISSUE OF INADVERTENT PACING IS CONSIDERED A REP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8473543 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090017. One submission often covers many models, so check the product and lot details in each record.

• Z-1230-2012 · Feb 9, 2012 · Terminated
  CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
• Z-1839-2011 · Feb 15, 2011 · Terminated
  10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole ca
• Z-0884-2011 · Oct 5, 2010 · Terminated
  CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster ele
• Z-2369-2012 · Nov 17, 2009 · Terminated
  CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a