CARTO 3 FG540000Recalls & reported problems

Summary

The FDA's MAUDE database contains 437 adverse event reports that list this exact device (DI 10846835000870), received between Jan 11, 2018 and Aug 20, 2026 — classified as 1 death, 23 injuries, 413 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (214 reports).

5 other recalls cover devices cleared under the same FDA submission (K072202, K090017, K170600, K173977, K173978, K180238, K191660, K200484, K213264, K221112, K223733, K231207, K252302, K252972, K254085); 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 25 most recent of 437 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50356660 ↗
• MalfunctionJun 30, 2026Device Emits Odor; Electrical Shorting

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT)) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND A BURNING SMELL WAS NOTICED. DURING THE CASE, THE BWI REPRESENTATIVE GOT A CURRENT LEAKAGE DETECTED ERROR. SHE UNPLUGGED AND REPLUGGED ALL THE CABLES AND ISSUE WAS GONE. AT THE END OF THE CASE SHE CHECKED EVERYTHING AND NOTICED A BURNING SMELL BUT DIDN'T KNOW FROM WHERE IT HAS BEEN COMING FROM. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO EXCESSIVE AMOUNT OF HEAT DURING USE. THERE WERE NO VISIBLE SIGNS OF FLAMES COMING FROM THE SYSTEM. NO PART OF THE EQUIPMENT WAS MELTING/CARBONIZING. IT WAS A GRILLED SMELL AND AN UNEXPECTED SMELL IN THE LAB, WE DIDN¿T IDENTIFY FROM WHERE IT HAS BEEN COMING FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674116 ↗
• MalfunctionApr 14, 2026Display or Visual Feedback Problem; Poor Quality Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A CARTO 3 SYSTEM AND WHILE USING AN ABLATION CATHETER, THE MEDICAL TEAM HAD LOST VISUALIZATION OF THE CATHETER AND THERE WAS A MAP SHIFT ON THE CARTO. NO ERRORS IN ERROR LIST. CATHETER VISUALIZATION DID NOT RETURN IMMEDIATELY AFTER PULSE FIELD ABLATION (PFA). WHEN IT EVENTUALLY REAPPEARED, IT WAS OUTSIDE OF THE LEFT ATRIUM (LA) BODY. THE MAP NEVER SHIFTED BACK UNTIL POST MAPPING BEGAN. THE PATIENT DID NOT MOVE OR COUGH PRIOR TO THE MAP SHIFT. THERE WAS NO CARDIOVERSION PERFORMED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877938 ↗
• MalfunctionMar 30, 2026Pacing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION AFIB, PAROXYSMAL ABLATION PROCEDURE WITH A CARTO 3 AND WHEN PACING AROUND THE VARIPULSE CATHETER, THE PACING CHANNELS SELECTED ON THE RECORDING SYSTEM DID NOT MATCH WHAT WAS BEING DISPLAYED AS PACING ON THE CARTO 3 SYSTEM. THE REPORTER STATED THAT WHEN PACING FROM VARIPULSE 9/10 ON THE RECORDING SYSTEM, IT WAS DISPLAYED AS 7/8 ON THE CARTO 3 SYSTEM. WHEN PACING FROM VARIPULSE 7/8, IT WAS DISPLAYED AS 6/7 ON THE CARTO 3 SYSTEM. ALL THE REST WERE NORMAL. THERE WERE NO ISSUES WITH ANY OTHER BI-POLES. IT WAS NOTED THAT MORE LESION TOUCHUPS HAD TO BE PERFORMED DURING THE PROCEDURE. THERE WAS NO TROUBLESHOOTING PERFORMED AND THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT RESOLUTION. THE VARIPULSE CATHETER WAS BRAND NEW. THERE WERE 30 LESIONS APPLIED BEFORE PACING OCCURRED AND THE ISSUE WAS NOTICED. A DIRECT CONNECT IC OUT CABLE WAS USED. ADDITIONAL INFORMATION INDICATED THAT PACING AND ABLATING SIMULTANEOUSLY WAS NOT ATTEMPTED. NOTHING WAS CONNECTED TO THE DIRECT PACING PORT. THE VARIPULSE WAS PLUGGED INTO PIU PORT 20A, AND PACING WAS ROUTED USING THE RECORDING SYSTEM AS NORMAL. MICROPACE WAS USED AS THE PACING STIMULATOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716697 ↗
• MalfunctionMar 25, 2026Display or Visual Feedback Problem; Computer Operating System Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM AND THERE WAS A MAP SHIFT WITH NO ERROR MESSAGE, NO PATIENT MOVEMENT AND NO CARDIOVERSION PERFORMED PRIOR TO THE SHIFT. AFTER A PDFA APPLICATION WITH THE FARAWAVE CATHETER, THERE APPEARED TO BE A MAP SHIFT ON THE CARTO 3 SYSTEM MAP. WHEN ATTEMPTING TO VISUALIZE THE FARAWAVE CATHETER, THE SYSTEM DISPLAYED "SNAPSHOT COULD NOT BE TAKEN" AND THE SYSTEM FROZE. THEY ATTEMPTED TO RELOAD THE APPLICATION USING THE CARTO HOTKEYS. THERE WAS A NOTICEABLE DELAY IN THE APPLICATION RELOADING. A NEW STUDY WAS STARTED DUE TO CONCERNS OF A CORRUPTED STUDY. THE PROCEDURE CONTINUED. THE TEMPLATE WAS NOT IN USE. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-MAR-2026. THE SYSTEM DID NOT PROVIDE AN ERROR. THE SHIFT WAS DISCOVERED BY SEEING NOTHING LINING UP AND THE FARAWAVE CATHETER OUT THE FAM. THE ISSUE WAS SEEN DURING ABLATION. THE APPROXIMATE DIFFERENCE IN MAP LOCATION BEFORE AND AFTER THE MAP SHIFT WAS UNKNOWN. IT WAS QUITE A LARGE CHANGE. SEVERAL CM LIKELY. THE PHYSICIAN DID NOT PERFORM A CARDIOVERSION PRIOR TO THE MAP SHIFT. THE PATIENT DID NOT MOVE BEFORE DETECTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695109 ↗
• MalfunctionMar 4, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 AND THERE APPEARED TO BE A MAP SHIFT ON THE CARTO 3 SYSTEM WHEN USING THE FARAWAVE PETAL CATHETER. THE PETAL SW IS INSTALLED ON THE SYSTEM. THERE WAS NO ERROR CODE DISPLAYED ON THE SYSTEM. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508696 ↗
• MalfunctionFeb 25, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VARIPULSE CATHETER AND A CARTO 3 SYSTEM AND SIGNAL NOISE OCCURRED ON ALL OF THE ECG AND INTRACARDIAC (IC) SIGNALS WITHOUT ANY OTHER MONITORS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. IT WAS INITIALLY REPORTED THAT THE INTRACARDIAC SIGNALS FROM THE CATHETERS WERE ATTENUATED. EACH CATHETER WITH A SENSOR WAS TAKEN OUT ONE BY ONE. WHEN THE VARIPULSE CATHETER WAS TAKEN OUT, THE NOISE ISSUE RESOLVED. THE CASE WAS ALMOST OVER SO THEY DID NOT REPLACE THE VARIPULSE CATHETER. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED NOISE ON SIGNALS IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 4-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING NOISE WAS OBSERVED ON ALL ECG AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE ANY OTHER MONITOR AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. THE CATHETER WAS IN THE PATIENT AT THE TIME OF INCIDENT. BASED ON THE NEW INFORMATION RECEIVED, THE EVENT WAS ASSESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449630 ↗
• MalfunctionFeb 12, 2026Display or Visual Feedback Problem; Poor Quality Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THERE WAS A MAP SHIFT OF APPROXIMATELY 2MM WITHOUT ANY ERROR MESSAGES, WHICH RESOLVED ON ITS OWN. DURING ABLATION, THE CATHETER WAS MAKING VERY STRANGE MOVEMENTS ON THE CARTO SCREEN. THERE WAS A VISUALIZATION ISSUE AS WHERE THERE WAS NO HIS SIGNAL BEFORE, THERE WAS SUDDENLY A HIS SIGNAL SHOWING. AFTER A WHILE, THE SHIFT RESOLVED ITSELF BECAUSE WHERE THE MEDICAL TEAM IDENTIFIED HIS SIGNAL THERE WAS SUDDENLY NO HIS SIGNAL ANYMORE. THE CASE WAS CONTINUED WITHOUT DELAY OR ISSUE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326556 ↗
• MalfunctionFeb 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND NEAR THE END OF THE PROCEDURE A MAP SHIFT WAS NOTED. NO ERROR WAS NOTED ON THE CARTO 3 SYSTEM. A QUADRIPOLAR WAS AT THE SAME PLACE OF THE RIGHT ATRIUM (TAGGED HIS) SINCE THE BEGINNING OF THE PROCEDURE; HOWEVER, THERE WAS A 10MM DOWNWARD MAP SHIFT. THERE WAS NO PATIENT MOVEMENT, COUGHING, ARM REPOSITIONING, OR CARDIOVERSION PRIOR TO NOTING THE MAP SHIFT. THERE WERE NO CHANGES TO THE PATIENT'S BREATHING AS WELL. THE PROCEDURE WAS CONTINUED TO COMPLETION SINCE THE MEDICAL TEAM WAS FINISHED ABLATING BY THE TIME THEY NOTICED THE ISSUE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272693 ↗
• MalfunctionFeb 4, 2026Display or Visual Feedback Problem

  IT WIT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM WHICH ENCOUNTERED A MAP SHIFT WITHOUT ANY ERRORS, NO PATIENT MOVEMENT AND NO PATIENT CARDIOVERSION. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THEY HAD MAP SHIFT WITHOUT ANY WARNING AND THEY HAD TO REMAP BECAUSE OF THIS ISSUE. THERE WERE NO PATIENT CONSEQUENCES. THE CASE WAS COMPLETED. THE CUSTOMER'S MAP SHIFT ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THIS IS NORMAL OR EXPECTED RESPONSE FROM THE SYSTEM. THERE IS NO SYSTEM MALFUNCTION. ON 27-JAN-2026 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ISSUE WAS NOTICED DURING ABLATION AFTER MAPPING. THERE WAS NO WARNING IN THE SYSTEM. WE SAW THAT THE PATCHES HAD SHIFTED BY PRESSING CTRL + P, AND IT WAS ALREADY NOTICEABLE ON THE MAP. EACH PATCH SHOWED A SHIFT OF AT LEAST 15MM. IT WAS REPORTED THE MAP SHIFT OCCURRED BEFORE CARDIOVERSION WAS PERFORMED. THE PATIENT DID NOT MOVE, COUGH NOR HAD THEIR HEAD RAISED, REPOSITIONED OR PILLOW ADJUSTED. THE PATIENT'S ARM WAS NOT MOVED WITHOUT CHANGING THE PATIENT'S POSITION ON THE MATTRESS AND THE PATIENT'S BREATHING OR VENTILATION DID NOT CHANGE BEFORE THE MAP SHIFT. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260801 ↗
• MalfunctionJan 22, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM WHICH ENCOUNTERED A MAP SHIFT WITHOUT ANY ERRORS, NO PATIENT MOVEMENT AND NO PATIENT CARDIOVERSION. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT PREMAP WAS COMPLETED WITH THE OCTARAY CATHETER. THEN THEN GAVE THERAPY WITH THE VARIPULSE CATHETER. WHEN POST THERAPY MAPPING WAS COMPLETED THREE OF THE FOUR PULMONARY VEINS WERE NOT ISOLATED. USING TPI VISITAGS PROJECTION THE VARIPULSE CATHETER APPEARED TO HAVE CONTACT WITH THE TISSUE. THEY HAD TO FINISH ISOLATING THE VEINS WITH A QDOT CATHETER. CALLER STATED THERE IS A CONCERN THAT THE MAP WAS NOT ACCURATE AND THAT WAS THE REASON THEY DID NOT ACHIEVE ISOLATION OF ALL FOUR VEINS WITH THE VARIPULSE CATHETER. THERE WAS NO PATIENT MOVEMENT AND NO ERRORS ON CARTO. ON 27-DEC-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO ERROR WAS SHOWN ON THE CARTO 3 SYSTEM OF A MAP SHIFT. ONLY INDICATION THAT MAYBE THERE WAS ONE WAS THAT THE THERAPY WAS NOT EFFECTIVE IN ISOLATING 3 OF THE 4 PULMONARY VEINS. THE MAP SHIFT IS THE BEST ASSUMPTION THE FIELD SERVICE TEAM COULD COME UP WITH WHEN THE ISSUE WAS CALLED IN. EITHER THE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141785 ↗
• MalfunctionJan 15, 2026Failure to Power Up; Smoking; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND SMOKE CAME OUT FROM THE SMALL HOLE PRESENT ON THE LEFT CORNER OF THE MONITOR. THEY RECEIVED A BROKEN MONITOR, THE SCREEN WAS PHYSICALLY DAMAGED. THE SYSTEM WAS BEING INSTALLED AT THAT MOMENT. NO PATIENT INVOLVED. A NEW MONITOR FOR THE CARTO 3 SYSTEM WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. THE BWI REPRESENTATIVE ADVISED THAT THE SYSTEM IS NOT INSTALLED YET SINCE THE INSTALLATION WILL BE PERFORMED ON (B)(6) 2026, BUT THE BWI REPRESENTATIVE OPENED THE BOXES, MONITOR AND WORKSTATION (WS) ONLY, TO GET THE UID FOR THE WS AND REQUEST THE LICENSES IN ORDER TO BE READY FOR THE INSTALLATION DAY. ONCE CONNECTED THE MONITOR AND WS, THEY NOTICED THAT THE MONITOR WAS NOT TURNING ON AT ALL SINCE DEFECTIVE. THE MONITOR GOT DAMAGED ON THE SCREEN AND SMOKE CAME OUT FROM THE SMALL HOLE PRESENT ON THE LEFT CORNER. ISSUE OBSERVED AND FACED DURING MONITOR INSTALLATION ONCE CONNECTED TO THE POWER AND SWITCHED ON. NO PATIENT OR PROCEDURE INVOLVED DURING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. ONCE CONNECTED MONITOR AND WS, THEY NOTICED THAT THE MONITOR WAS TURNI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077743 ↗
• MalfunctionJan 12, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THERE WAS A MAP SHIFT WITH APPROXIMATELY 2-3 CM BETWEEN CATHETER AND MAP LOCATION. THE CARTO 3 SYSTEM DID NOT PROVIDE ANY ALERTS OR ERRORS RELATED TO THE ISSUE. THERE WAS NO PATIENT MOVEMENT, HEAD MOVEMENT, COUGHING, OR ARM REPOSITIONING PRIOR TO NOTING THE ISSUE. THE MEDICAL TEAM HAD TO REMAP BEFORE PROCEEDING WITH THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044969 ↗
• MalfunctionJan 12, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) PROCEDURE WITH A CARTO 3 SYSTEM AND THE THERMOCOOL SMARTTOUCH SF CATHETER SIGNAL DISAPPEARED AND WAS LOW AND NOISY, NOISE THAT WAS INITIALLY IDENTIFIED ON THE BODY SURFACE (BS) PRIOR TO A PUNCTURE ON THE PATIENT. THE NOISE WAS OBSERVED ON BOTH THE CARTO AND GE CARDIOLAB. THE PHYSICIAN CONFIRMED THAT THEY DID NOT HAVE ANY OTHER AVAILABLE ELECTROCARDIOGRAM SIGNAL TO MONITOR THE PATIENT'S HEART RHYTHM. THE PATIENT INTERFACE UNIT WAS RESTARTED BUT THE ISSUE PERSISTED. THE PHYSICIAN THEN DISCONNECTED ALL THE CABLES ATTACHED AT THE FRONT OF THE PATIENT INTERFACE UNIT (PIU) AND RESTARTED THE PIU AND ISSUE GONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044554 ↗
• MalfunctionDec 31, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) AND WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH A CARTO 3. INITIALLY, IT WAS INDICATED THAT THE ELECTROCARDIOGRAM (ECG) SIGNAL WAS LOW AND NOISY, ON ALL LEADS, ON BOTH CARTO AND EPRS. IT WAS WORKING FINE AT THE BEGINNING WHEN THEY CONNECTED IT, BUT THE ISSUE HAPPENED RANDOMLY JUST AFTER THE PUNCTURE. THEY TRIED THE FOLLOWING TROUBLESHOOTING, BUT NOTHING HELPED. THEY HAD TO REPLACE THE BS ECG CABLE WITH THE SAME SPARE CABLE FROM THE SAME LAB. THEY DISCONNECTED AND RECONNECTED THE BS ECG CABLE. THEY CHECKED THE STICKY PATCHES ON THE PATIENT AND PRESSED THEM TO RE-APPLY SOME PRESSURE. THEY RESTARTED THE PIU, THE WORKSTATION, THE EPRS AND THE NGEN SYSTEM (GENERATOR, CONSOLE, MONITORS AND PUMP). THEY DISCONNECTED ALL CABLES IN THE FRONT OF THE PATIENT INTERFACE UNIT (PIU), EXCEPT THE BS ECG CABLE ONE AND RESTARTED THE PIU AND RECONNECTED THE CABLES ONE BY ONE, BUT THE ISSUE REMAINED. IT WAS NOTED THAT WHEN THE PIU WAS TURNED OFF, THE SIGNAL WENT BACK TO NORMAL, BUT THE ISSUE CAME BACK WHEN THEY TURNED BACK ON THE PIU. THE PROCEDURE WAS COMPLETED WITH A SPARE BS ECG CABLE. THERE WERE NO PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932177 ↗
• MalfunctionDec 22, 2025Computer Software Problem; Device Emits Odor; Computer Software Problem; Device Emits Odor

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO 3 AND THERE WAS A SMELL OF BURN AFTER THE PROCEDURE ONCE THE STUDY EXITED IN CARTO 3. IT WAS INDICATED THAT AFTER AN ACCESSORY PATHWAY PROCEDURE, THE WORKSTATION HAD AN ISSUE ON THE FAN. THE DELL SUPPORT ASSIST DISPLAYED A MESSAGE INDICATING THAT THE FAN FAILED TO RESPOND CORRECTLY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO VISIBLE SIGN OF FIRE OR FLAMES. THERE WAS NO EXCESSIVE AMOUNT OF HEAT DURING USE. THERE WAS NO PART OF THE EQUIPMENT THAT WAS MELTING/CARBONIZED. THERE WAS NO VISIBLE SIGN OF SMOKE, JUST UNEXPECTED SMELL. IT SMELLED LIKE BURN, BUT IT WAS NOT CLEAR AND DIFFICULT TO IDENTIFY WHERE THE SMELL CAME FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873830 ↗
• MalfunctionDec 15, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND A MAP SHIFT OCCURRED WITHOUT ANY PATIENT MOVEMENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AT THE END OF THE PROCEDURE THE RIGHT OBLIQUE ARC WAS MANIPULATED AND WHEN RETURNING TO EP IT WAS DETECTED THAT THE MAP HAD MOVED. THE CUSTOMER¿S REPORTED MAP SHIFT IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THIS IS NORMAL OR EXPECTED RESPONSE FROM THE SYSTEM TO MOVEMENT. THERE IS NO SYSTEM MALFUNCTION. ON 18-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SYSTEM DIDN'T INDICATE ANY ALERTS. THE DISPLACEMENT WAS NOTICED BECAUSE WE WERE MAPPING FOR THE FIRST TIME AND PERFORMING AN ABLATION. SUBSEQUENTLY, WE WANTED TO REMAP, AND WHEN MAPPING THE SAME AREA, THE FAST ANATOMICAL MAPPING (FAM) WAS PERFORMED AT A CONSIDERABLE DISTANCE. LATER, WE CONFIRMED WITH FLUOROSCOPY IMAGES THAT WE WERE INDEED IN THE SAME AREA BUT THERE WAS A MEASURED THE DISTANCE BETWEEN MAPS AT THE END OF THE PROCEDURE OF 8MM. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND DID NOT MOVE PRIOR TO DETECTING THE MAP SHIFT. THE PATIENT DID NOT COUGH, THERE WAS NO CHANGE IN THE PATIENT¿S BREATHING OR VENTILATION AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802812 ↗
• MalfunctionDec 1, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO¿ 3 SYSTEM AND AFTER MAPPING THE LEFT ATRIUM AND THEN ADVANCING THE FARAWAVE¿ PULSED FIELD ABLATION (PFA) CATHETER INTO THE LEFT ATRIUM, IT WAS NOTICED THAT THE ENTIRE CHAMBER ON THE MAP APPEARED TO BE "SHIFTED" APPROXIMATELY 1 INCH SUPERIORLY. THE FARAWAVE¿ PFA CATHETER WAS VISUALIZED MORE INFERIORLY, BELOW THE CHAMBER. THE LOCATION OF THE FARAWAVE¿ PFA CATHETER WAS VERIFIED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE) ON THE ULTRASOUND SYSTEM. THERE WERE NO ERRORS DISPLAYED ON THE CARTO¿ 3 SYSTEM AT THE TIME, AND NO PATIENT MOVEMENT/CARDIOVERSION OBSERVED. THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE UTILIZING ICE FOR CATHETER VISUALIZATION INSTEAD. AFTERWARDS, WHEN THE OCTARAY¿ CATHETER WAS RE-INSERTED BACK INTO THE IN THE LEFT ATRIUM FOR A POST-MAP, THE MAP AND VISUALIZATION ON THE CARTO¿ 3 SYSTEM HAD RETURNED TO NORMAL. THE PROCEDURE CONTINUED. THE MAP SHIFT WAS ONLY SEEN DURING ABLATION WITH THE FARAWAVE¿ PFA CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23685293 ↗
• MalfunctionNov 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THE MAP SHIFTED WITHOUT THE MEDICAL TEAM RECEIVING A WARNING MESSAGE/ERROR. THE SHIFT WAS DISCOVERED AS THE LOCATION OF THE MAPPING CATHETER (PENTARAY) THAT WAS OUTSIDE OF THE MAP. BY CREATING A NEW MAP OF THE LEFT ATRIUM, THE TEAM DISCOVERED THAT THE MAP WAS SHIFTED. THE APPROXIMATE DIFFERENCE IN MAP LOCATION BEFORE AND AFTER MAP SHIFT WAS 2CM. PRIOR TO THE SHIFT, THERE WAS NO CARDIOVERSION, PATIENT MOVEMENT, COUGHING, BREATHING/VENTILATION CHANGES IDENTIFIED. THERE WAS A 15-MINUTE DELAY AS THE MEDICAL TEAM REDID THE MAP. THE PROCEDURE CONTINUED AND COMPLETED WITH A NEW MAP. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654252 ↗
• MalfunctionNov 20, 2025Electrical /Electronic Property Problem; Device Emits Odor; Electrical /Electronic Property Problem; Device Emits Odor

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM AND THERE WAS A BURN SMELL FROM THE PATCH UNIT. PATCH NUMBER 2 OF THE GREEN CABLE BECAME STRIPY IN INTERMITTENCE DURING THE PROCEDURE. MANAGED TO FINISH BY MOVING THE CABLE SLIGHTLY. NO HARM ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 31-OCT-2025 INDICATED THAT THERE WAS A BURN SMELL FROM THE PATCH UNIT. THE PATCH WAS NO LONGER VISIBLE. TRIED WITH ANOTHER PU WHICH SOLVED THE ISSUE. THE EVENT IS CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 31-OCT-2025 OF A BURN SMELL FROM THE PATCH UNIT AND HAVE REASSESSED THIS ISSUE AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 31-OCT-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612377 ↗
• MalfunctionNov 20, 2025Signal Artifact/Noise; Application Program Problem; Signal Artifact/Noise; Application Program Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A CARTO 3 AND THERE WAS NOISE ON THE ECG CABLE SIGNALS. DURING THE SETUP OF THE CASE, THERE WAS NOISE ON THE ECG CABLE SIGNALS AND AN ERROR #1201 - ECG LIMB LEAD DISCONNECTION. THEY CHECKED ALL THE CONNECTIONS, AND EVERYTHING WAS SECURELY ATTACHED. THE CABLE WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. INITIALLY, THE EVENT WAS ASSESSED AS NOT MDR REPORTABLE. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON 24-OCT-2025, AND IT WAS INDICATED THAT THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON BOTH THE CARTO® AND RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. THIS WAS NOT THE FIRST USE OF THE INVOLVED BS ECG CABLE. WITH THE ADDITIONAL INFORMATION, THE EVENT IS NOW CONSIDERED MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612059 ↗
• MalfunctionNov 4, 2025Display or Visual Feedback Problem; Poor Quality Image; Display or Visual Feedback Problem; Poor Quality Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM AND A MAP SHIFT WITH NO ERROR MESSAGE, NO PATIENT MOVEMENT AND NO CARDIOVERSION PRIOR TO MAP SHIFT OCCURRED. A MAP SHIFT OCCURRED ON THE CARTO 3 SYSTEM AS SOON AS THE OCTARAY CATHETER WAS REMOVED FROM THE BODY. THEY VISUALIZED THE CORONARY SINUS (CS) CATHETER SHIFT ON THE CARTO 3 SYSTEM AS SOON AS THE OCTARAY CATHETER WAS REMOVED FROM THE BODY. THERE WAS NO CARDIOVERSION OR PATIENT MOVEMENT. THERE WERE NO ERRORS DISPLAYED ON THE CARTO 3 SYSTEM. THE FARAWAVE CATHETER WAS INACCURATELY DISPLAYED ON THE CARTO 3 SYSTEM DURING THE ENTIRE ABLATION. THE PROCEDURE CONTINUED WITHOUT RESOLUTION. NO PATIENT CONSEQUENCE WAS REPORTED. THE SMARTABLATE AND FARAPULSE SYSTEMS WERE USED FOR ABLATION. THE PETAL XML WAS USED. ADDITIONAL INFORMATION WAS RECEIVED. THE APPROXIMATE DIFFERENCE IN MAP LOCATION BEFORE AND AFTER MAP SHIFT WAS 2CM. NO CHANGES IN THE PATIENT'S BREATHING OR VENTILATION BEFORE THE MAP SHIFT. THE PATIENT¿S HEAD WAS NOT RAISED OR REPOSITIONED ON THE PILLOW. THE PATIENT¿S ARM DID NOT MOVE WITHOUT CHANGING THE PATIENT¿S POSITION ON THE MATTRESS. THE FARAWAVE WAS CONNECTED AT THE TIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472124 ↗
• MalfunctionOct 29, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND A MAP SHIFT OCCURRED DURING PROCEDURE WITHOUT ANY PATIENT MOVEMENT OR PRIOR CARDIOVERSION. DURING THE PROCEDURE, WHILE USING A JET VENTILATOR, A MAP SHIFT OCCURRED ON THE CARTO 3 SYSTEM MAP. THE CALLER STATED THAT THERE WAS NO PATIENT MOVEMENT, NO ERRORS DISPLAYED, AND THEY WERE NOT RESPIRATORY GAITED. THERE WAS NOT A TEMPLATE IN USE. THE CALLER STATED THAT ALTHOUGH THERE WERE NO ERRORS PRESENT IT WAS VERY OBVIOUS THAT THERE WAS A 1-2 MM DIFFERENCE IN THE MAP. THE CALLER STATED THAT THEY ALSO USED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TO CONTINUE AND COMPLETE THE PROCEDURE. ON 13-OCT-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ISSUE OCCURRED DURING THE ABLATION PHASE. THERE WERE NO ERRORS FROM THE SYSTEM AND THE VISITAGS FROM PREVIOUS ABLATIONS DID NOT ALIGN WITH THE CURRENT VISUALIZATION OF THE ABLATION CATHETER. THERE WAS NO PATIENT MOVEMENT DETECTED BEFORE THE SHIFT, THE PATIENT WAS NOT CARDIOVERTED. THERE WAS NO CHANGE IN THE PATIENT¿S BREATHING AND THE PATIENT DID NOT COUGH OR HAVE HEAD RAISED OR ARM REPOSITIONED. BASED ON THE ADDITIONAL INFORMATION RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413336 ↗
• MalfunctionOct 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM AND THE REPORTED MAP SHIFT WITH NO ERROR MESSAGE, NO PATIENT MOVEMENT AND NO CARDIOVERSION PRIOR TO THE MAP SHIFT OCCURRED. DURING AN ATRIAL FIBRILLATION PROCEDURE, WHILE USING A JET VENTILATOR, A MAP SHIFT OCCURRED ON THE CARTO 3 SYSTEM MAP. NO PATIENT MOVEMENT, NO ERRORS DISPLAYED, AND THEY WERE NOT RESPIRATORY GATED. THERE WAS NO A TEMPLATE IN USE. ALTHOUGH THERE WERE NO ERRORS PRESENT, IT WAS VERY OBVIOUS THAT THERE WAS A 1-2 MM DIFFERENCE IN MAP. THEY ALSO USED ICE TO CONTINUE AND COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 03-OCT-2025. THE ISSUE WAS SEEN DURING ABLATION. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT. THE PATIENT DID NOT COUGH BEFORE DETECTING THE SHIFT. THE CRNA STATED THERE WERE NO CHANGES IN THE PATIENT¿S BREATHING NOR VENTILATION BEFORE THE MAP SHIFT. THE PATIENT¿S ARM WAS NOT MOVED WITHOUT CHANGING THE PATIENT¿S POSITION ON THE MATTRESS. THE REPORTED MAP SHIFT ISSUE WITH NO ERROR MESSAGE AND NO PATIENT MOVEMENT IS ASSESSED AS NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 03-OCT-2025 THAT THE THEY DID NOT PERFORM A C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23409026 ↗
• MalfunctionOct 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 AND A MAP SHIFT SHOWING THE CORONARY SINUS (CS) CATHETER WAS OUTSIDE OF THE MAPPING SHELL, AFTER SEVERAL PULSED FIELD ABLATIONS (PFA). THE LOCATION PAD WAS OFF DURING THE PFA APPLICATIONS. THERE WAS NO ADVERSE PATIENT CONSEQUENCE THAT WAS REPORTED. ADDITIONAL INFORMATION WAS PROVIDED, AND IT WAS INDICATED THAT A FARAWAVE CATHETER DID NOT LINE UP WITH THE GEOMETRY. THE ISSUE WAS SEEN DURING ABLATING. THE APPROXIMATE DIFFERENCE IN MAP LOCATION BEFORE AND AFTER MAP SHIFT WAS A FEW MILLIMETERS. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT. THE PATIENT DID NOT MOVE NOR COUGH BEFORE DETECTING THE SHIFT. THERE WERE NO CHANGES IN THE PATIENT'S BREATHING OR VENTILATION BEFORE THE MAP SHIFT. THE PATIENT'S HEAD WAS NOT RAISED NOR REPOSITIONED ON THE PILLOW. THE PATIENT'S ARM WAS NOT MOVED WITHOUT CHANGING THE PATIENT'S POSITION ON THE MATTRESS. A FARAWAVE (NON-J&J CATHETER) WAS CONNECTED AT THE TIME OF OCCURRENCE. THE MAP SHIFT OCCURRED WITH BOTH THE FARAWAVE CATHETER, AS WELL AS WITH THE J&J CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072202, K090017, K170600, K173977, K173978, K180238, K191660, K200484, K213264, K221112, K223733, K231207, K252302, K252972, K254085. One submission often covers many models, so check the product and lot details in each record.

• Z-2880-2020 · Jun 22, 2020 · Terminated
  CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. Th
• 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