TRUPULSE™ Generator D141702Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10846835025248), received between Jan 6, 2025 and Sep 29, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (4 reports).

1 other recall cover devices cleared under the same FDA submission (P240006); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026High Readings; Power Problem; Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50939124 ↗
• MalfunctionSep 16, 2026Device Emits Odor

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794335 ↗
• MalfunctionSep 11, 2026Mechanical Jam

  It was reported that a patient underwent a Pulse Field Ablation (PFA) procedure for Atrial Fibrillation (AFib) with a TRUPULSE GENERATOR and the foot pedal became stuck and continued ablation. It was also reported that during the procedure, when the physician had released the nGEN¿ Foot Pedal in order to come off PFA ablation, the TRUPULSE¿ Generator did not stop or cut off PFA ablation. The caller confirmed that there were no errors or alerts displayed on the TRUPULSE¿ Generator. The caller reported that they were able to come off PFA ablation by manually selecting "Stop" on the TRUPULSE¿ monitor instead. The caller reported that the physician did not feel comfortable continuing ablation with the same nGEN¿ Foot Pedal. The nGEN¿ Foot Pedal was replaced with one from another system, and the procedure was continued with no other issues. The caller confirmed that a TRUPULSE¿ Generator was in use for ablation at the time of the issue.Additional information received indicated that when pressed, the foot pedal did ablate but the foot pedal got stuck and continued ablating. Ablation was stopped by pressing the button on the monitor. There were no error codes or alarms.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725666 ↗
• MalfunctionApr 20, 2026Unexpected Shutdown

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A TRUPULSE¿ GENERATOR AND AFTER ABOUT 15-20 ABLATIONS, COMING ON THE THIRD APPLICATION, THE TRUPULSE¿ SYSTEM SHUT OFF ON ITS OWN AND REBOOTED AUTOMATICALLY. THIS THEN RECURRED APPROXIMATELY FIVE LESIONS LATER. AFTER THE SYSTEM REBOOTED EACH TIME, THE MEDICAL TEAM WAS ABLE TO CONTINUE WITH NORMAL FUNCTIONALITY OF THE TRUPULSE¿ SYSTEM AND AFTER THE SECOND REBOOT, THE SYSTEM FUNCTIONED WITH NO ISSUE FOR THE REMAINDER OF THE CASE. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931678 ↗
• MalfunctionApr 8, 2026Decreased Pump Speed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A TRUPULSE GENERATOR AND NO ALARM WAS GENERATED WHEN THE SALINE BAG RAN OUT. IT WAS REPORTED BY THE CALLER, THAT AFTER UPGRADING TO THE NEW SOFTWARE OF THE TRUPULSE¿ GENERATOR, THE VARIPULSE¿ PLUS UPDATE, WHILE TESTING THE LOW FLUID ALARM SETTING THERE WAS NO AUDIBLE SOUND FROM THE GENERATOR OR THE REMOTE, OR ANY WARNINGS ON THE SCREEN EITHER. THE CALLER ADDED THAT THEY SET THE IRRIGATION TO 250MLS AT LOW FLOW AND THE THRESHOLD WAS SET TO 225ML AND LET THE BAG RUN OUT, BUT NO ALARM WAS GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824607 ↗
• MalfunctionApr 3, 2026Decreased Pump Speed

  IT WAS REPORTED THAT THE TRUPULSE WAS UPGRADED TO EE SOFTWARE 2.2.2.31. THE FLUID COUNTER WAS READING THE WRONG AMOUNT OF FLUID. LOW FLUID WARNING ALERT DID NOT STOP THE GENERATOR FROM ABLATING WHEN FLUID COUNT REACHED ZERO. THE IV (INTRAVENOUS) BAG STILL HAD FLUID. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773102 ↗
• MalfunctionMar 18, 2026Communication or Transmission Problem; Protective Measures Problem; Unexpected Shutdown

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) AND CAVOTRICUSPID ISHMUS (CTI) PROCEDURE WITH A TRUPULSE¿ GENERATOR AND THERE WAS A SUDDEN TRUPULSE¿ GENERATOR SHUT OFF WHILE AN ABLATION BEING PERFORMED ISSUE OBSERVED. AFTER (10-15) ABLATIONS, THEY WERE COMING ON ABLATION WITH THE VARIPULSE¿ CATHETER AND THE TRUPULSE¿ GENERATOR AND THE MONITORS (PRIMARY AND SECONDARY) SHUT DOWN AND REBOOTED. THE CARTO¿ 3 SYSTEM DISPLAYED AN ALERT "LOST COMMUNICATION TO THE ABLATION GENERATOR." THE CALLER STATED THE TRUPULSE¿ GENERATOR REINITIALIZED AND RE-CONNECTED TO THE CARTO¿ 3 SYSTEM WITH NO ERRORS DISPLAYING. THE PROCEDURE CONTINUED AND THE ISSUE OCCURRED AGAIN AND REPEATED MULTIPLE TIMES THROUGHOUT THE PROCEDURE. THE CALLER NOTED THAT THE LAST TIME IT REBOOTED, THE TRUPULSE¿ MONITOR DISPLAYED AN ERROR 203, "CONSOLE WAITING FOR VOLTAGE TO REACH TARGET." THE CALLER NOTED THAT THE ERROR THEN DISAPPEARED AFTER 2 SECONDS, THE SYSTEM RE-INITIALIZED ITSELF AND THE PROCEDURE CONTINUED. THE PROCEDURE THEN CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 18-FEB-2026 WHICH INDICATED THAT THERE WAS SUDDEN TRUPULSE¿ GENERAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626410 ↗
• MalfunctionMar 16, 2026Unexpected Shutdown

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A TRUPULSE¿ GENERATOR. ABOUT 15 ABLATIONS COMPLETED. ON THE 3RD OUT OF 3 PULSES DELIVERY, THE GENERATOR SHUT OFF UNEXPECTEDLY. DURING THE SHUTOFF, THE TRUPULSE¿ GENERATOR MONITORS FLASHED OUT AND THEY BOTH BEGAN A REBOOTING SEQUENCE. ON THE PRIMARY TRUPULSE¿ GENERATOR MONITOR, THE MESSAGE READ - CARTO® 3 SYSTEM INITIALIZING, AND THE TRUPULSE¿ SYSTEM RESTARTED. THEY COULD CONTINUE WITH THE PROCEDURE. THE ISSUE WAS ONLY EXPERIENCED ONCE. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610806 ↗
• MalfunctionMar 13, 2026Communication or Transmission Problem; Unexpected Shutdown

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND HALFWAY THROUGH THE CASE, AFTER ABOUT 15 LEGIONS, THEY CAME ON ABLATION WITH THE VARIPULSE¿ CATHETER, AND THE TRUPULSE¿ GENERATOR AND PRIMARY MONITOR BOTH SHUT OFF. THERE WERE NO ERRORS DISPLAYED. AFTER 4-5 SECONDS, IT REBOOTED ITSELF, AND THE MONITOR CAME BACK ON WITH NO CONNECTION TO CARTO¿ 3 SYSTEM WHICH DISPLAYED AN ALERT MESSAGE "LOST COMMUNICATION TO THE ABLATION GENERATOR." THE TRUPULSE¿ GENERATOR AND MONITORS WERE SHUT DOWN, REBOOTED IN SEQUENCE AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590704 ↗
• MalfunctionFeb 12, 2026Unintended Power Up

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A TRUPULSE¿ GENERATOR AND OBSERVED THE CATHETER WOULD ABLATE ON ITS OWN. A VARIPULSE¿ CATHETER HAD AN ERROR - 20 POLE CONNECTION ERROR (DID NOT KNOW THE FULL ERROR MESSAGE OR ERROR CODE) DISPLAYED ON THE CARTO® 3 SYSTEM AND SHORTLY AFTER, THE CATHETER WOULD ABLATE ON ITS OWN. THEY HIT THE STOP BUTTON ON THE GENERATOR AND WHEN THEY CONTINUED TO ABLATE, THE ISSUE DID NOT REOCCUR AND WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCE WAS REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE ERROR WAS ASSESSED AS NON MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE ISSUE OF THE CATHETER WOULD ABLATE ON ITS OWN WAS ASSESSED AS MDR REPORTABLE UNDER THE TRUPULSE¿ GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328680 ↗
• MalfunctionDec 26, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND WHEN THE DOCTOR CHANGED CATHETERS TO A PENTARAY, THE DOCTOR NOTICED SOME CHARRING ABOVE THE ELECTRODE. THE SETTINGS ARE KNOWN FROM PREVIOUS COMPLAINTS ON THE SUBJECT OF CHARRING. THE PATIENT HAD NO COMPLICATIONS. THE CHARRING WAS BETWEEN THE TIP ELECTRODE AND ELECTRODE. NO ERROR MESSAGES WERE NOTED PRIOR TO THE DISCOVERY. THERE WERE NO TEMPERATURE OR FLOW ISSUES EITHER. THE CORRECT CATHETER SETTINGS HAD BEEN SELECTED. THE GENERATOR PARAMETERS WERE: QMODE+4S 16 90W ¿ TEMPERAURE TARGET: 55°C TEMPERATURE CUT OFF: 65°C 5. THE PATIENT WAS ANTICOAGULATED WITH AN ACTIVATED CLOTTING TIME (ACT) OVER 300, A VALUE WHICH WAS MAINTAINED THROUGHOUT THE CASE. THE PHYSICIAN CONSIDERED THE AMOUNT OF CHAR TO BE EXCESSIVE AND TO PRESENT A POTENTIAL PATIENT RISK. THERE WERE NO ABLATIONS THAT USED FOR ABOVE 40G FOR EXTENDED PERIODS OF TIME--THE PHYSICIAN AIMS FOR 5-15G. HEPARANIZED NORMAL SALINE WAS USED FOR IRRIGATION. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898516 ↗
• MalfunctionDec 26, 2025High Readings; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A TRUPULSE GENERATOR THAT INDICATED ELEVATED IMPEDENCE READINGS. THE MEDICAL TEAM WAS UNABLE TO COMPLETE A TPI (TISSUE PROXIMITY INDICATION) CALIBRATION AS THE IMPEDANCE READINGS WERE RANGING IN THE 260 OHM RANGE. HOWEVER, NO ERRORS WERE DISPLAYED FOR THE IMPEDENCE VALUES OR ANY OTHER ISSUE ON THE TRUPULSE GENERATOR OR CARTO 3 SYSTEM. THE STOP BUTTON WAS FUNCTIONING. THE REPROCESSED GENERATOR CABLE WAS REPLACED WITH A NEW OUT OF THE BOX CABLE WITHOUT RESOLUTION. THE CATHETER WAS ALSO REPLACED WITHOUT RESOLUTION. THE CATHETER AND CABLE WERE EXCHANGED A SECOND TIME AND THE ISSUE PERSISTED. NEXT, THE CABLE FROM THE GENERATOR TO THE PATIENT INTERFACE UNIT (PIU) HAD BEEN REPLACED. THE GENERATOR HAD THEN BEEN REBOOTED. MEANWHILE, THE PHYSICIAN CONTINUED TO ABLATE WITH A THIRD VARIPULSE CATHETER. WHEN THE CATHETER WAS ADVANCED TO THE RSPV (RIGHT SUPERIOR PULMONARY VEIN), THE IMPEDANCE VALUES ELEVATED ABOVE RANGE AND ALL VALUES WERE RED. THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898282 ↗
• MalfunctionDec 18, 2025High Readings; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A TRUPULSE¿ GENERATOR AND THE SYSTEM DISPLAYED A "HIGH CURRENT ON ELECTRODE 3" ERROR. IT WAS REPORTED THAT WHEN PULSING THE RIGHT SUPERIOR, THE TRUPULSE¿ SYSTEM DISPLAYED A "HIGH CURRENT ON ELECTRODE 3" ERROR. THEY TRIED TO PULSE ON A DIFFERENT PART OF THE VEIN WITHOUT RESOLUTION. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839592 ↗
• MalfunctionDec 16, 2025Unintended Power Up; Communication or Transmission Problem; Unintended Power Up; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A TRUPULSE GENERATOR, US, AND AN ERROR 202 CIU NOT CONNECTED OCCURRED (MEANING CONTROL INTERFACE UNIT). WHEN THE CATHETER WAS IN THE RSPV (RIGHT SUPERIOR PULMONARY VEIN) THE PHYSICIAN COULDN'T DELIVER PFA (PULSE FIELD ABLATION) WITH FOOT PEDAL. THE J&J REP PRESSED STOP BUTTON TO CLEAR THE ERROR, AND WHILE STANDING AT THE CONSOLE THE SYSTEM STARTED AUTOMATICALLY DELIVERING PFA. IT HAPPENED TO BE IN A SPOT THAT THEY WANTED TO DELIVER SO THE PHYSICIAN LET THE GENERATOR DELIVER A FULL ROUND OF PULSES. THEY PRESSED STOP BUTTON CONTINUOUSLY AND THE PHYSICIAN DISCONNECTED THE CATHETER. THE 202 ERROR WAS STILL PRESENT. THE TRUPULSE GENERATOR WAS REBOOTED AND THE ERROR 202 CLEARED. HOWEVER, THE PHYSICIAN OPTED TO CONTINUE THE CASE WITH A NGEN RF GENERATOR. THE PROCEDURE WAS CONTINUED AND COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823930 ↗
• MalfunctionSep 5, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) - PAROXYSMAL ABLATION PROCEDURE WITH A TRUPULSE¿ GENERATOR. WHEN RELEASING THE TRUPULSE¿ FOOT PEDAL TO STOP PULSED FIELD ABLATION (PFA) DELIVERY, THE ENTIRE PFA SEQUENCE CONTINUED THROUGHOUT FOR 30 SECONDS, AND DID NOT STOP AS EXPECTED. NO TROUBLESHOOTING WAS DONE AFTER THIS. THE ISSUE DID NOT HAPPEN AGAIN, AND THE PHYSICIAN DID NOT HAVE TO COME OFF FOOT PEDAL AGAIN PREMATURELY. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE FOOT PEDAL DID NOT GET STUCK. WHEN PRESSED, IT ABLATED AND CONTINUED TO ABLATE EVEN WHEN THE PEDAL WAS RELEASED THROUGH THE ENTIRETY OF THE 20 SECOND SEQUENCE. THE DISTANCE BETWEEN THE REMOTE AND THE CLOSEST MAGNET WAS APPROXIMATELY 10 FEET AWAY FROM THE MAGNET. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975608 ↗
• MalfunctionAug 5, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A TRUPULSE GENERATOR, US AND THE PHYSICIAN HAD RELEASED THE PEDAL AFTER THE FIRST DELIVERY AND THE GENERATOR STILL APPEARED AS IT WAS LOADING FOR THE NEXT ABLATION. AND THEN THE NEXT DELIVERY STILL WENT THROUGH ALL BY ITSELF. THE THIRD DELIVERY WAS STOPPED BY USING THE CONSOLE. THE PEDAL WAS CHECKED AND WAS FOUND WORKING JUST FINE, AND THE MEDICAL TEAM SUSPECTED A GENERATOR ISSUE AND REQUESTED FOR A FIELD SERVICE ENGINEER TO INSPECT THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722607 ↗
• MalfunctionJul 18, 2025Failure to Power Up; Smoking; Failure to Power Up; Smoking

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A TRUPULSE GENERATOR, US AND IT WAS NOT POWERING ON. THE MONITOR AND REMOTE HAD POWER. BUT THERE WERE NO LIGHTS OR NOISES COMING FROM THE CONSOLE. DIFFERENT OUTLETS WERE TRIED, THE POWER CABLE WAS RESEATED, AND THEY EXCHANGED THE POWER CABLE--ALL WITHOUT RESOLUTION. THE CONSOLE WAS REPLACED AND THE PROCEDURE CONTINUED. HOWEVER, A FIELD SERVICE ENGINEER WENT ONSITE AND FOUND AN ERROR 4 ON TWO DIFFERENT MONITORS/STANDS. THE CONSOLE WAS REPLACED AND BOOTED UP WITHOUT ERRORS. BUT AFTER 5 MINUTES THE CONSOLE SHUT OFF AND STARTED SMOKING OUT OF THE SIDES. THE POWER WAS DISCONNECTED. THE ENGINEER TESTED OUTLETS WITH A VOLTMETER AFTER WAITING FOR THE SMOKE TO CLEAR THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546793 ↗
• MalfunctionJan 6, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A TRUPULSE¿ GENERATOR AND WHEN THE PHYSICIAN STEPPED ON THE TRUPULSE FOOT PEDAL, ABLATION CAME ON BUT WHEN HE RELEASED THE FOOT PEDAL, ABLATION DID NOT COME OFF, IT CONTINUED. THIS OCCURRED NEAR THE END OF THE PROCEDURE; THEREFORE, THE FOOT PEDAL WAS NOT REPLACED. A COUPLE MORE LESIONS WERE DONE USING THE PRIMARY MONITOR TO STOP ABLATION. THERE WAS NO ERROR MESSAGE. THE FOOT PEDAL WAS TESTED IN THE TRUPULSE CONNECTIVITY TAB AND THERE WERE NO ISSUES. IN ADDITION, THE FOOT PEDAL WAS TESTED POST CASE AND THE ISSUE COULD NOT BE REPLICATED. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080890 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P240006. One submission often covers many models, so check the product and lot details in each record.

• Z-1205-2025 · Jan 5, 2025 · Completed
  VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recordin