nGEN Generator D138402Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10846835018080), received between May 23, 2023 and Jan 21, 2026 — classified as 2 deaths, 13 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (13 reports).

12 other recalls cover devices cleared under the same FDA submission (P010068, P030031, P040036, P950005, P990025, P990071); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Unintended Power Up

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE AND THE NGEN¿ SYSTEM ACTIVATED ABLATION ON ITS OWN. THE REPORT INDICATED THAT THEY WERE IN THE CONTROL ROOM AT THE TIME, SO THEY DID NOT SEE IT HAPPEN. THE PHYSICIAN STATED THAT THEY DID NOT STEP ON THE FOOT PEDAL AND NO ONE PRESSED ANY BUTTONS ON THE GENERATOR TO ACTIVATE ABLATION. RIGHT BEFORE THE ABLATION ACTIVATED ON ITS OWN, THE CARTO 3 SYSTEM DISPLAYED A 106-FORCE SENSOR ERROR. WHEN THE CABLE WAS REPLACED, THE ISSUE WAS RESOLVED. THEY DID NOT KNOW IF THE ERROR WAS RELATED TO THE ISSUE WITH THE NGEN¿ SYSTEM ACTIVATING ABLATION. THEY IMMEDIATELY PRESSED THE STOP BUTTON WHEN THE NGEN¿ GENERATOR ACTIVATED ABLATION ON ITS OWN. NO INJURY TO THE PATIENT WAS REPORTED. THEY CONTINUED USING THE SAME NGEN¿ GENERATOR TO ABLATE FOR THE REST OF THE PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT ABLATION MODE AND THRESHOLDS WERE: QMODE, 3 WATTS; TARGET 50C; CUTOFF 55 C. THE TEMPERATURE, IMPEDANCE, AND POWER WERE: 3 WATTS, UNKNOWN IMPEDANCE; TEMP 37C. THEY MANUALLY PRESSED THE STOP BUTTON ON PRIMARY MONITOR. THE FOOT PEDAL WAS NOT STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133952 ↗
• MalfunctionDec 30, 2025Unintended Power Up; Failure to Discharge; Unintended Power Up; Failure to Discharge

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND THE NGEN HAD AN ERROR - FOOT PEDAL STUCK, AND ABLATION WOULD NOT START. THEY REBOOTED THE NGEN AND MONITORS AND ABLATION STARTED WITH THE FOOT PEDAL NOT DEPRESSED. THERE WAS NO INJURY TO THE PATIENT. THEY REPLACED THE FOOT PEDAL WITH ONE THEY HAD AS EXTRA AND HAD A BENT PIN AND THE ISSUE DID NOT RESOLVE. THEY REPLACED THE GENERATOR CONSOLE AND RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930055 ↗
• InjuryNov 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A QDOT MICRO CATHETER AND AN NGEN GENERATOR AND SUFFERED AN ESOPHAGEAL PERICARDIAL FISTULA WHICH REQUIRED AN ESOPHAGUS PATCH AND THE PERICARDIAL SAC FLUSHED. THE PATIENT HAD AN ESOPHAGEAL PERICARDIAL FISTULA. THE FISTULA DID NOT GO ALL THE WAY TO THE ATRIUM. THE PATIENT WENT INTO THE EMERGENCY ROOM (ER) IN (B)(6) 2025 ABOUT 2-3 WEEKS FOLLOWING THE PROCEDURE. UNABLE TO PROVIDE DETAILS ABOUT THE PATIENT SYMPTOMS AND UNSURE WHAT SPECIFIC DATE THE PATIENT CAME INTO THE ER. THE EVENT WAS REPORTED TO THE JNJ REPRESENTATIVE ON (B)(6) 2025. FLUID WAS NOTICED IN THE THORACIC SPACE. IT WAS UNKNOWN HOW THE INJURY WAS CONFIRMED, AND MORE TESTING WAS PERFORMED. THE ESOPHAGUS WAS PATCHED UP AND THE PERICARDIAL SAC HAD TO BE FLUSHED OUT A FEW TIMES. THE PATIENT'S PERICARDIAL SAC HAD TO BE FLUSHED OUT BECAUSE THE FISTULA IN THE ESOPHAGUS WAS LEAKING FLUID AND ACIDS INTO THE PERICARDIAL SAC. THE LAST KNOWN PATIENT STATUS WAS ALIVE AND DISCHARGED. A QDOT MICRO CATHETER WAS USED FOR ABLATION. QMODE PLUS WAS USED. THE NGEN GENERATOR WAS USED FOR ABLATION AND CARTO 3 SYSTEM WAS USED FOR MAPPING. MULTIPLE ATTEMPTS HAVE

  Patient problems: Fistula

  MAUDE report 23453087 ↗
• MalfunctionSep 3, 2025Protective Measures Problem; Unintended Electrical Shock; Protective Measures Problem; Unintended Electrical Shock

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB)/FLUTTER ABLATION PROCEDURE WITH A NGEN GENERATOR AND WHEN THE GENERATOR WAS UNPLUGGED, AN ELECTRICAL SHOCK WAS FELT. IT WAS REPORTED BY THE CALLER THAT SHE RECEIVED AN ELECTRICAL SHOCK WHEN SHE UNPLUGGED THE NGEN GENERATOR POWER SUPPLY DURING A PROCEDURE. THE CALLER UNPLUGGED THE GENERATOR FROM THE ELECTRICAL OUTLET, AS PART OF TROUBLESHOOTING STEPS TAKEN TO CORRECT ERROR CODE 201, CONSOLE MALFUNCTION. THE CALLER STATES THAT SHE IS "FINE" AND WAS NOT INJURED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE THMCL SMARTTOUCH, TC, J, C3 CATHETER WAS IN THE BODY WHEN THE EVENT OCCURRED. HOWEVER, NO STAFF OR PHYSICIAN EXPERIENCED A SHOCK. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND SO THE CALLER IS NOT AWARE OF ANY PATIENT DISCOMFORT. THERE WAS NO RESISTANCE CONNECTING THE CABLE TO THE CATHETER. THE COMPATIBILITY OF THE CABLE AND THE CATHETER WAS CORRECT AND CONFIRMED PRIOR TO CONNECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949699 ↗
• InjuryAug 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN ATRIO-ESOPHAGEAL FISTULA (AEF) OCCURRED AFTER AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT CATHETER AND NGEN GENERATOR. IT WAS REPORTED THAT AN AEF WAS NOTICED IN THE PATIENT. IT IS UNKNOWN WHAT DATE THE INJURY WAS DISCOVERED, OR IF IT OCCURRED DURING THE ATRIAL FIBRILLATION CASE, HOW THE AEF WAS DISCOVERED, OR HOW IT WAS CONFIRMED. THE PATIENT WAS OBSERVED UNDER CRITICAL CONDITION AND REQUIRED INTERVENTION EXTENDED HOSPITALIZATION FOR OBSERVATION. THE PATIENT WAS STABLE AT THE TIME OF REPORTING. THE INFORMATION RECEIVED INDICATED THAT THE ESOPHAGEAL INJURY WAS CONFIRMED. THE NUMBER OF PERFORMED ABLATIONS WAS 228 WITH RADIOFREQUENCY ENERGY DELIVERED. THE GENERATOR ABLATION MODE USED WAS QMODE+ ON POSTERIOR WALL, AND THE FORCE VISUALIZATION FEATURES USED DASHBOARD, VECTOR, AND VISITAG. THE VISITAG PARAMETERS FOR STABILITY MODULE USED RANGE 2-2.5MM AND TIME 3-5SEC. THE ADDITIONAL FILTER USED WITH THE VISITAG WAS ABLATION INDEX, WITH COLOR OPTION PROSPECTIVELY USED WAS OTHER TAG INDEX. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR, AND NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION.

  Patient problems: Fistula

  MAUDE report 22852497 ↗
• InjuryAug 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 21 DAYS AFTER AN ATRIAL FIBRILLATION (AFIB) RADIO FREQUENCY (RF) ABLATION WITH A QDOT MICRO CATHETER AND A NGEN GENERATOR, THE PATIENT EXPERIENCED AN ESOPHAGEAL FISTULA TREATED WITH SURGICAL REPAIR. IT WAS REPORTED 21 DAYS AFTER THE PROCEDURE, THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) WITH ABNORMAL LABS. THE PATIENT WAS TAKEN TO SURGERY AND A "DIME SIZED" ESOPHAGEAL FISTULA WAS FOUND. THE ESOPHAGEAL FISTULA WAS REPAIRED WITHIN THE OPERATING ROOM (OR). THE PHYSICIAN INDICATED THAT THE PATIENT WAS SLOWLY RECOVERING BUT REMAINED IN STABLE CONDITION. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE QDOT MICRO CATHETER AND THE NGEN GENERATOR.

  Patient problems: Fistula

  MAUDE report 22835401 ↗
• MalfunctionAug 7, 2025Unintended Power Up; Failure to Discharge; Unintended Power Up; Failure to Discharge

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN NGEN GENERATOR. IT WAS REPORTED THAT A FOOT PEDAL NOT CONNECTED ERROR (UNKNOWN ERROR CODE) WAS DISPLAYED ON THE NGEN MONITOR. WHEN INSPECTING THE NGEN FOOT PEDAL CONNECTION AT THE NGEN CONSOLE, THE PORT WAS NOTICED TO BE LOOSE. WHEN THE NGEN FOOT PEDAL CONNECTION WAS WIGGLED AT THE NGEN CONSOLE PORT, THE NGEN GENERATOR ERRONEOUSLY DELIVERED ABOUT 20 SECONDS OF ABLATION TO THE PATIENT EVEN THOUGH THE FOOT PEDAL OR START BUTTON WAS NOT PRESSED. THE STOP BUTTON WAS PRESSED TO STOP ABLATION. THE NGEN FOOT PEDAL WAS DISCONNECTED COMPLETELY FROM THE NGEN CONSOLE AND WAS DISABLED FROM THE NGEN MONITOR. THE PROCEDURE CONTINUED WITH MANUAL ABLATION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. GENERATOR WAS IN QMODE. TEMP/IMPEDANCE WERE DEFAULT SETTINGS. TIME CUTOFF 60 SECONDS. POWER SET AT 30W. THE TEMPERATURE, IMPEDANCE AND POWER VALUES WERE NOT NOTED. THE CUTOFF VALUES WERE NOT EXCEEDED. FOOT PEDAL WAS NOT STUCK. THE ABLATION WAS STOPPED BY USING THE RED STOP BUTTON ON THE MONITOR. THE FOOT PEDAL NOT CONNECTED ERROR CODE WAS ASSESSED AS NON MDR REPORTABLE. THE MOST LIKELY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745866 ↗
• MalfunctionJul 25, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A NGEN GENERATOR AND THERE WAS A FOOT PEDAL STUCK ISSUE OBSERVED. IT WAS REPORTED THAT ERROR 80, INVALID FORCE MEASUREMENTS WERE DISPLAYED ON THE CARTO 3 SYSTEM. THE CATHETER WAS INSIDE THE SHEATH WHEN THE ERROR OCCURRED. THE NGEN GENERATOR FOOT PEDAL WAS NOT RESPONDING AND THAT THE ONLY LIGHT ILLUMINATED ON THE NGEN GENERATOR WAS THE POWER BUTTON. ADVISED TO REBOOT THE NGEN GENERATOR AND THE CARTO 3 SYSTEM WITH THE ABLATION CATHETER DISCONNECTED. UPON REBOOT, A "FOOT PEDAL STUCK" ERROR WAS DISPLAYED. ADVISED TO CONNECT THE FOOT PEDAL TO THE MONITOR AND TO REBOOT NGEN GENERATOR. THE PHYSICIAN OPTED TO CONTINUE MAPPING. CALLED BACK TO CONTINUE TROUBLESHOOTING. REBOOTED THE NGEN GENERATOR MULTIPLE TIMES. THEY CONFIRMED THAT THE FOOT PEDAL WAS CONNECTED TO THE CONSOLE. THEY STATED THAT THE PRIMARY MONITOR HAD A ¿START BUTTON STUCK¿ MESSAGE. THE CALLER REBOOTED THE NGEN GENERATOR WITH CABLES DISCONNECTED FROM THE CONSOLE- NO RESOLUTION. ADVISED TO POWER DOWN THE NGEN GENERATOR, DISCONNECT THE PSU FOR AT LEAST 20 SECONDS, THEN POWER BACK ON. ADVISED TO CONNECT THE FOOT PEDAL TO THE MONIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610984 ↗
• MalfunctionJun 24, 2025Intermittent Continuity; Mechanical Jam; Intermittent Continuity; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN NGEN GENERATOR AND THE FOOT PEDAL BECAME STUCK. IT WAS REPORTED THAT A PEDAL STUCK ERROR (ERROR 2) WAS BEING DISPLAYED ON THE NGEN MONITOR. THE CALLER STATED THAT A LOW-FLOW MISMATCH ERROR (ERROR 52) WAS ALSO DISPLAYED ON THE NGEN MONITOR. THE CALLER STATED THAT THE NGEN PUMP WAS RUNNING AT 15 ML. THE NGEN PUMP WAS REBOOTED AND THE ISSUES WERE RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE NGEN GENERATOR WAS USED FOR ABLATION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324775 ↗
• MalfunctionJun 9, 2025Device Remains Activated; Activation, Positioning or Separation Problem; Device Remains Activated; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE WITH NGEN GENERATOR REMOTE STOP BUTTON MID PROCEDURE. WHEN THEY TRIED COMING OFF ABLATING, ABLATION WOULD NOT STOP. THEY HAD TO PRESS THE STOP BUTTON REALLY HARD LOCATED IN THE FRONT OF THE NGEN GENERATOR REMOTE MULTIPLE TIMES TO STOP ABLATING. THERE WAS NO VISIBLE DAMAGE TO THE REMOTE START BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168793 ↗
• MalfunctionJun 5, 2025Device Remains Activated; Activation, Positioning or Separation Problem; Device Remains Activated; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH NGEN GENERATOR AND WHEN THEY TRIED TO COME OFF ABLATION WITH THE REMOTE STOP BUTTON, ABLATION WOULD NOT STOP. THERE WAS AN ISSUE WITH THE WITH NGEN GENERATOR REMOTE STOP BUTTON MID PROCEDURE. WHEN THEY TRIED COMING OFF ABLATING, ABLATION WOULD NOT STOP. THEY HAD TO PRESS THE STOP BUTTON LOCATED IN THE FRONT OF THE NGEN GENERATOR REMOTE MULTIPLE TIMES TO STOP ABLATING. THE PROCEDURE THEN CONTINUED WITHOUT ANY FURTHER ISSUES. THERE WAS NO VISIBLE DAMAGE TO THE REMOTE START BUTTON. REQUESTED THE START BUTTON TO BE REPAIRED. ADDITIONAL INFORMATION WAS RECEIVED. ABLATION MODE AND THRESHOLDS; NGEN- IMPEDANCE CUT OFF 250 AND TEMPERATURE CUT OFF 40. THE NOTED MAX TEMPERATURE WAS 31, MAX IMPEDANCE 240 AND POWER 40. THE CUT OFF VALUES WERE NOT EXCEEDED. FOOT PEDAL NOT IN USE. EP LAB TECHNICIAN HAD TO PRESS STOP BUTTON MULTIPLE TIMES BEFORE IT WOULD STOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155130 ↗
• MalfunctionMay 7, 2025Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WHICH INCLUDED THE USE OF A NGEN GENERATOR AND WHEN IMMEDIATELY STARTING ABLATION, AND AFTER STOPPING ABLATION WITH THE FOOT PEDAL, THE FLOW RATE STILL USES THE LOW FLOW RATE INSTEAD OF NORMAL HIGH FLOW RATE WITH ABLATING. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PUMP STAYED AT 4ML OF FLOW PRE-ABLATION AND FOR THE ENTIRE DURATION OF ABLATION. THE PUMP NEVER RESET TO BASELINE 2ML OF FLOW BEFORE THE NEXT LESION START. IT NEVER ACHIEVED HIGH FLOW AT 15ML DURING ABLATION EVEN AS TEMPERATURE APPROACHED AND SURPASSED THE MAX TEMP SETTING. THEREFORE, ONLY POWER WAS TITRATED DURING ABLATION AND NOT FLOW RATE. THERE WERE NO ERRORS ON THE NGEN GENERATOR NOR ON CARTO. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981966 ↗
• InjuryMay 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN ATRIAL FIBRILLATION AND ATRIAL FLUTTER ABLATION PROCEDURE WITH A QDOT MICRO AND AN NGEN GENERATOR AND THE PATIENT EXPERIENCED AN ESOPHAGEAL FISTULA THAT REQUIRED "MEDICAL INTERVENTION". AFTER A RIGHT-SIDED ATRIAL FLUTTER AND ATRIAL FIBRILLATION PROCEDURE WAS COMPLETED ON (B)(6) 2025, AN ESOPHAGEAL FISTULA WAS NOTICED IN THE PATIENT ON (B)(6) 2025. WHEN THE PATIENT WENT BACK TO A DIFFERENT HOSPITAL ON (B)(6) FOR A CHECK-UP, IT WAS NOTICED THAT THE PATIENT HAD SOME "ESOPHAGEAL DAMAGE." IT IS UNKNOWN HOW THE ESOPHAGEAL DAMAGE WAS DISCOVERED. IT WAS REPORTED THAT AN ESOPHAGEAL FISTULA WAS CONFIRMED IN THE PATIENT, BUT IT IS UNKNOWN HOW IT WAS CONFIRMED. MEDICAL INTERVENTION WAS PROVIDED TO THE PATIENT, BUT THE SPECIFIC TYPE OF INTERVENTION IS UNKNOWN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS CONFIRMED THERE WAS "ESOPHAGEAL COOLING" UTILIZED DURING THE PROCEDURE ON (B)(6). IT WAS NOTED THAT THEY NOTICED DAMAGED ON PATIENT INTERFACE UNIT (PIU) MAP PINS. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT WIDE ANTRAL CIRCUMFERENTIAL ABLATION (WACA) RAN BEHIND THE ESOPHAGUS (

  Patient problems: Fistula

  MAUDE report 21979732 ↗
• MalfunctionApr 1, 2025Device Emits Odor; Noise, Audible; Device Emits Odor; Noise, Audible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PULSE FIELD ABLATION PROCEDURE WITH A NGEN GENERATOR AND WHILE THE PATIENT WAS ON THE TABLE, ONE OF THE SALINE PRESSURE BAGS GOT A PIN HOLE IN IT AND STARTED SPRAYING ON THE NGEN POWER SUPPLY UNIT. WHEN THE SALINE SPRAYED ONTO THE POWER SUPPLY UNIT, WHICH WAS POWERED ON, IT SMELLED LIKE SMOKE AND STARTED POPPING AND CRACKING. THE NGEN SYSTEM WAS NOT BEING USED AT THE TIME BUT WAS POWERED ON. THE SALINE DIDN'T GET ON ANY OTHER BIOSENSE WEBSTER INC. EQUIPMENT AND NO OTHER AREAS WERE AFFECTED. THE POWER SUPPLY UNIT WAS UNPLUGGED FROM BOOM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746655 ↗
• DeathMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ATRIAL TACHYCARDIA ABLATION WITH A THERMOCOOL SMARTTOUCH SF AND A NGEN GENERATOR AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. ROUGHLY ONE MONTH AFTER AN ATRIAL FIBRILLATION PROCEDURE WAS PERFORMED, AN ESOPHAGEAL FISTULA WAS NOTICED. THE PATIENT CALLED THE OFFICE AFTER FEELING CHEST PAINS ROUGHLY ONE MONTHS AFTER THE PROCEDURE. THE PATIENT PASSED AWAY ON THEIR WAY TO THE EMERGENCY ROOM (ER). IT WAS UNKNOWN HOW THE INJURY WAS CONFIRMED OR IF ANY MEDICAL INTERVENTION WAS PROVIDED FOR THE PATIENT. THERE WERE NO COMPLICATIONS DURING THE INITIAL PROCEDURE. THEY BELIEVE THE INJURY WAS CAUSED BY BURNING AT HIGH POWER IN THE POSTERIOR WALL USING A RADIO FREQUENCY CATHETER. IT WAS REPORTED THAT THEY WERE "NO LONGER A CLINICAL AT THIS ACCOUNT AND IS NOW DOING CLINICAL THERAPY ADVANCEMENT". OCTARAY CATHETER, SOUNDSTAR CATHETER AND A THERMOCOOL SMARTTOUCH SF CATHETER WERE USED DURING THE PROCEDURE. THE PROCEDURE WAS PERFORMED ROUGHLY 12 MONTHS AGO, THE EVENT WAS REPORTED NOW BECAUSE THEY DID NOT KNOW IT WAS PREVIOUSLY REPORTED AND THEY JUST FOUND OUT ABOUT THE EVENT. THE EVENT WAS JUST FOUND OUT AND IT WAS REPORTED THAT T

  Patient problems: Fistula

  MAUDE report 21684817 ↗
• MalfunctionFeb 12, 2025Smoking; Unexpected Shutdown; Smoking; Unexpected Shutdown

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NGEN GENERATOR AND THEY HEARD A LOUD AUDIBLE NOISE THAT CAME FROM THE VICINITY OF THE NGEN GENERATOR. THEY WENT TO ENSURE THE GENERATOR WAS FUNCTIONING PROPERLY. THEY THEN NOTICED THAT THE NGEN GENERATOR WAS POWERED OFF COMPLETELY AND A "LOST COMMUNICATION WITH NGEN" MESSAGE APPEARED ON THE CARTO 3 SYSTEM. THEY POWERED ON THE NGEN GENERATOR AND THE NGEN GENERATOR MADE A LOUD "BOOM" NOISE. IT WAS NOTED THAT THE NGEN BEGAN TO SPARK AND SMOKE. THE REPORTER DID NOT PERSONALLY SEE ANY FIRE OR FLAMES; HOWEVER, THE NURSE STANDING NEXT TO THE REPORTER STATED THAT SHE SAW SPARKS. THEY COULD JUST SMELL THE SMOKE AND IT SMELLED LIKE SOMETHING WAS BURNING. THE NGEN SYSTEM WAS POWERED DOWN AND UNPLUGGED FROM THE POWER SOURCE. THE CASE CONTINUED WITHOUT THE USE OF THE NGEN. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370281 ↗
• MalfunctionNov 19, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A NGEN RF GENERATOR, US CONFIGURATION AND THE MEDICAL TEAM KEPT GETTING A FOOT PEDAL STUCK ERROR, WHICH THEN STOPPED ABLATION. THE PEDAL WAS AT LEAST 'A FEW FEET AWAY' FROM ANY MAGNETS. THE NGEN FOOT PEDAL WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729743 ↗
• MalfunctionOct 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT NGEN MONITOR 23200009FM WAS INSTALLED. HOWEVER, IT WAS DISCOVERED THAT THE LABELS WERE SWAPPED WITH MONITOR 23260080FM AND THE MONITOR 23260080FM WAS ACTUALLY INSTALLED WITH WRONG LABEL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517449 ↗
• MalfunctionSep 24, 2024Unintended Power Up; Communication or Transmission Problem; Unintended Power Up; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NGEN RF GENERATOR, US AND THE FOOT PEDAL GOT STUCK. INITIALLY, IT WAS REPORTED THAT ABLATION DATA WASN'T COMMUNICATING TO THE WORKSTATION. THE TEAM INSPECTED THE ETHERNET CABLE AND SAW THAT THE CONNECTED WAS DAMAGED AND NOT SEATING CORRECTLY. WHILE THE MEDICAL TEAM WAS ABLATING THEY STEPPED OFF THE FOOT PEDAL TO STOP ABLATION AND THE UNIT WAS STILL BEEPING LIKE THERAPY WAS STILL BEING DELIVERED. THE PEDAL WAS THEN MOVED AND IT WAS BEEPING AGAIN LIKE THERAPY WAS DELIVERED. THEY MOVED THE FOOT PEDAL CABLE FROM THE MONITOR TO THE CONSOLE AND THE ISSUE SEEMED TO RESOLVE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289480 ↗
• MalfunctionAug 21, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NGEN GENERATOR AND THE THE FOOT PEDAL WAS "STUCK". IT WAS REPORTED BY THE CALLER THAT THE PHYSICIAN STATED THAT THE FOOT PEDAL WAS "STUCK" AND NOT CLICKING LIKE THE OTHERS DO. A FOOT PEDAL FROM ANOTHER LAB WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020301 ↗
• InjuryAug 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED SKIN BURNS THAT REQUIRED BANDAGES. THE PROCEDURE OCCURRED ON (B)(6) 2024. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT WAS MOVED TO THE RECOVERY AREA. WHILE IN THE RECOVERY AREA, IT WAS NOTICED THAT THE PATIENT RECEIVED A BURN WHERE THE ABLATION GROUNDING PADS WERE PLACED. UNAWARE OF ANY MEDICAL INTERVENTIONS THAT WERE PROVIDED TO THE PATIENT. THE PATIENT WAS BELIEVED TO BE IN STABLE CONDITION. BANDAGE WAS APPLIED TO AREA POST CARE. PATIENT FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT THE BURN WAS CAUSED BY ONE OF THE PATCHES ON PATIENT CRUMPLING UP ON SKIN.

  Patient problems: Burn(s)

  MAUDE report 19996878 ↗
• MalfunctionAug 8, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED BY THE CALLER THAT THE QDOT ABLATION CATHETER TEMPERATURE WAS NOT REACHING 40 DEGREES, AS THE PHYSICIAN EXPECTED (BASED ON PAST PROCEDURES). THE CALLER STATED THAT THE TEMPERATURES WERE READING AROUND 36 DEGREES ON THE NGEN SYSTEM/CARTO 3 SYSTEM. THE CALLER STATED THAT SOME TOUCH-UP ABLATION WAS NEEDED IN ONE VEIN, BUT BLOCK WAS ACHIEVED. THE CALLER STATED THAT SIGNAL ATTENUATION WAS SEEN AS USUAL.. THE CALLER STATED THAT THE HEAT MAP WAS MOSTLY BLUE INSTEAD OF YELLOW/ORANGE AS SEEN IN PAST PROCEDURES. WHEN CHECKING THE VISITAGS FOR AVERAGE TEMPERATURE READINGS, THEY WERE AROUND 36 DEGREES. THE CALLER WAS ADVISED TO TRY A DIFFERENT TX ECO CABLE, AS WELL AS A DIFFERENT PIU TO CONSOLE CABLE FOR CASES TOMORROW. THIS ISSUE HAPPENED ON AN EARLIER CASE TODAY, PLEASE SEE (B)(4). THE CALLER IS REQUESTING A REPLACEMENT CATHETER. FSE DISPATCH REQUESTED FOR FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945253 ↗
• MalfunctionAug 6, 2024Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND NGEN GENERATOR AND WAS A ¿BURNING SMELL¿ BEING EMITTED. IT WAS REPORTED THAT THE PHYSICIAN SMELLED SOMETHING BURNING AT THE START OF THE CASE. THE CALLER NOTED THAT THE NGEN GENERATOR WAS ON, BUT THE PFA GENERATOR WAS USED FOR ABLATION. THE CALLER STATED THAT THE BURNING SMELL WAS STILL THERE BY THE END OF THE CASE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SMELL WAS COMING FROM WHERE THE CARTO 2 SYSTEM PATIENT INTERFACE UNIT (PIU) AND NGEN GENERATOR WERE LOCATED; HARD TO DECIPHER WHICH ONE WAS CAUSING THE ISSUE. THE SMELL WAS DESCRIBED AS AN UNEXPECTED ¿PLASTIC BURNING¿. THERE WERE NO VISIBLE FIRE OR FLAMES AND NO MELTING OR CARBONIZED EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919792 ↗
• MalfunctionJul 30, 2024Smoking; Communication or Transmission Problem; Protective Measures Problem; Smoking; Communication or Transmission Problem; Protective Measures Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A NGEN RF GENERATOR, US AND THE DEVICE SHORT CIRCUITED AND HAD SMOKE COMING OUT OF IT. THE SHORT CIRCUIT OCCURRED WHEN THE MEDICAL TEAM WAS CREATING A FAM (FAST ANATOMICAL MAPPING) MAP AND PLUGGED IN THE QDOT DONGLE. THE CARTO 3 SYSTEM DISPLAYED ERROR 218, : RF GENERATOR INCOMPATIBLE WITH QDOTTM CATHETER. THIS OCCURRED AFTER PLUGGING IN THE DONGLE TO THE PIU (PATIENT INTERFACE UNIT). THE CARTO 3 SYSTEM STOPPED CREATING A FAM MAP WITH ERROR DISPLAYED. THE TEAM DISCONNECTED THE QDOT DONGLE, REBOOTED THE NGEN GENERATOR AND REPLACED THE OCTARAY CABLE AND RESUMED CREATING A FAM MAP. HOWEVER, UPON RESEATING THE QDOT CABLE INTO THE PIU, ERROR 218,RF GENERATOR INCOMPATIBLE WITH QDOTTM CATHETER RETURNED. THE QDOT CABLE WAS REPLACED AND THE GENERATOR WAS REBOOTED A SECOND TIME WITHOUT RESOLUTION OF THE ISSUE. IT WAS THEN REPORTED THAT THE TEAM "DECIDED TO REPLACE AN ETHERNET CABLE" AND REBOOT THE NGEN GENERATOR AGAIN. ON THE THIRD REBOOT OF THE NGEN GENERATOR, THE LIGHTS ON THE FRONT PANEL TURNED SOLID RED. WHEN THEY TURNED ON THE MONITOR "SOMETHING IN THE GENERATOR SHORTED OUT AND THE GENERATOR STARTED S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19862769 ↗
• InjuryJul 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND NGEN RF GENERATOR AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT REQUIRED SURGICAL INTERVENTION. ALMOST TWO MONTHS AFTER AN AFIB CASE, THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA. PROCEDURE TOOK PLACE ON (B)(6) 2024 BUT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE INJURY ON (B)(6) 2024. COMPUTED TOMOGRAPHY (CT) CONFIRMED ESOPHAGEAL FISTULA. INTERVENTION WAS OPEN HEART SURGERY TO REPAIR HEART AND ESOPHAGUS. PATIENT WAS IN REHAB AND IMPROVING. HOWEVER, PATIENT REQUIRED EXTENDED HOSPITALIZATION AS THE PATIENT WAS IN THE HOSPITAL FOR ABOUT TWO WEEKS PRE AND POST SURGERY TO HELP RECOVER FROM THE INJURY. THE PHYSICIAN BELIEVED THE CAUSE OF THE ADVERSE EVENT WAS PROCEDURAL, AS THEY WERE BURNING TOO CLOSE TO THE ESOPHAGUS AND FOR TOO LONG. TEMPERATURE PROBE WAS USED TO MONITOR ESOPHAGEAL TEMPERATURE. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Fistula

  MAUDE report 19857504 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010068, P030031, P040036, P950005, P990025, P990071. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0058-2018 · Sep 6, 2017 · Terminated
  THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-3178-2011 · Jul 7, 2011 · Terminated
  STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequenc
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0981-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0980-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0369-2010 · Oct 2, 2008 · Terminated
  Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P
• Z-1328-04 · Jul 16, 2004 · Terminated
  Stockert 70 Radio Frequency Ablation Generator