Current™ PFA-GEN-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05415067051516), received between Mar 2, 2026 and Sep 28, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (7 reports).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Device Emits Odor; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917650 ↗
• MalfunctionSep 18, 2026Noise, Audible

  This report is to advise of thermal damage identified during device evaluation. During a pulsed field ablation atrial fibrillation procedure, a loud bang was heard from the Current PFA generator, and a PFA generator hardware error appeared on the screen. It was noted that mapping of atrial tachycardia in the left atrium had begun, and the capacitors were charged and ready for PFA delivery, but no PFA was delivered when the loud bang occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817779 ↗
• MalfunctionSep 17, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808695 ↗
• MalfunctionSep 11, 2026Output Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739588 ↗
• MalfunctionAug 20, 2026Thermal Decomposition of Device

  This report is to advise of thermal damage found during investigation.During a procedure with TactiFlex Duo catheter, the catheter was successfully connected to the Current generator and placed in the heart. The energy was charged to 100%. Before the first ablation, a loud sound was heard from the generator and an error message appeared which had a restart button. The exact message was not clear but it mentioned "low voltage detected". The generator was restarted two times with no resolution and another error appeared saying "Hardware issue detected". The generator was replaced and the procedure was completed with no adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50344456 ↗
• MalfunctionAug 13, 2026Thermal Decomposition of Device; Communication or Transmission Problem

  This report is to advise on thermal damage found during analysis.During an AF procedure using Rf and PFA (TactiFlex Duo), it was noted that the following error message was displayed on the Current generator; "Hard drive issue". The TactiFlex Duo catheter was replaced but the issue persisted. The procedure was completed using the TactiCath. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236650 ↗
• MalfunctionJul 28, 2026Thermal Decomposition of Device

  This report is to advise on thermal damage found during analysis. During an Endo-Epicardial VT procedure, both the TactiFlex Duo catheter and Advisor HD Grid catheter were used. Before ablation was started, it was made sure that everything was connected correctly. At that time, the Current PFA generator made a big sound and no longer functioned, despite it being restarted twice. The issue was resolved by using a different Current PFA generator to continue the case. The procedure was completed with no adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060457 ↗
• MalfunctionJul 8, 2026Thermal Decomposition of Device

  A REPORT IS NEEDED TO ADVISE OF THERMAL DAMAGE FOUND IN THE DEVICE DURING ANALYSIS. AFTER THE CASE, A LOUD POP SOUND CAME FROM THE CURRENT GENERATOR. AFTER, AN ERROR MESSAGE WAS DISPLAYED ON BOTH THE ENSITE X AND GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25749210 ↗
• MalfunctionJun 10, 2026Thermal Decomposition of Device

  THIS REPORT IS TO ADVISE OF THERMAL DAMAGE FOUND IN THE DEVICE DURING ANALYSIS. DURING A PROCEDURE, WHEN DELIVERING PFA APPLICATION A LOUD POP WAS HEARD FROM THE GENERATOR AND A GENERATOR FAULT MESSAGE DISPLAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453098 ↗
• MalfunctionJun 9, 2026Mechanical Problem; Noise, Audible

  DURING A PFA PROCEDURE, A "NOISE" WAS HEARD FROM THE CURRENT PFA GENERATOR AND A MESSAGE "VOLT GENERATOR HARDWARE ERROR. PLEASE REBOOT" WAS DISPLAYED ON THE ENSITE SYSTEM. TROUBLESHOOTING INCLUDED MULTIPLE REBOOTS OF THE GENERATOR WITH AND WITHOUT DEVICES OR CABLES CONNECTED, AS WELL AS TRYING DIFFERENT POWER OUTLETS, BUT THE ISSUE PERSISTED. IT WAS NOTED THAT THE STANDBY BUTTON WAS NOT ON DURING BOOTUP. THE ISSUE COULD NOT BE RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448770 ↗
• MalfunctionMay 18, 2026Communication or Transmission Problem

  THIS REPORT IS TO ADVISE OF THERMAL DECOMPOSITION THAT WAS NOTED DURING ANALYSIS. DURING A PFA PROCEDURE, WHEN CONNECTING THE TWO TOUCHSCREENS AND ADDING THE BOOM MONITOR VIA AN HDMI CABLE, IT WAS NOTED THAT THE SCREENS REMAINED BLACK. TYPICALLY, AFTER CONNECTING THE HDMI CABLE, THE TOUCHSCREENS WOULD GO BLACK FOR A SECOND BEFORE PROPERLY BOOTING UP. ON THE ENSITE X GUI, IT WAS SEEN THAT THE CURRENT PFA GENERATOR WAS STILL CONNECTED BUT, DESPITE MULTIPLE REBOOTS WITH DIFFERENT CABLE CONFIGURATIONS, NO IMAGES WERE ABLE TO POPULATE ON THE GENERATOR AFTER THE INITIAL ERROR. SINCE THE GENERATOR SCREEN WOULD NOT TURN ON, THE CASE WAS CONTINUED WITH A TACTIFLEX CATHETER. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200556 ↗
• MalfunctionMay 15, 2026Mechanical Problem; Noise, Audible

  DURING THE ATRIAL FIBRILLATION PFA PROCEDURE, ON THE 17TH PFA APPLICATION, THE CURRENT PFA GENERATOR PRODUCED A LOUD POPPING SOUND, AND A HARDWARE ERROR APPEARED ON THE MONITOR. THE SYSTEM PROMPTED US TO RESTART THE COMPUTER. HOWEVER, AFTER RESTARTING, A CASE COULD NOT BE STARTED, AND THE SYSTEM CONTINUOUSLY PROMPTED US TO REBOOT. EVEN AFTER DISCONNECTING ALL CABLES, AND REBOOTING THE SYSTEM AGAIN, THE ISSUE PERSISTED. PHYSICIAN DECIDED TO END THE PROCEDURE AND RE-DO IF THE ARRHYTHMIA RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187208 ↗
• MalfunctionMay 9, 2026Thermal Decomposition of Device

  THIS REPORT IS TO ADVISE OF THERMAL DAMAGE FOUND ON THE DEVICE DURING ANALYSIS. DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN USING THE VOLT 2.0 CATHETER IN THE LEFT ATRIUM, IT WAS NOTED THAT THE CURRENT PFA GENERATOR HAD RETURNED TO DEFAULT AFTER AN AUDIBLE SOUND WAS HEARD. SINCE A STUDY WAS UNABLE TO BE RAN ON THE CURRENT PFA GENERATOR AFTER, THE ISSUE WAS RESOLVED BY CHANGING TO A DIFFERENT SYSTEM TO CONTINUE THE CASE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25132842 ↗
• MalfunctionMay 7, 2026Communication or Transmission Problem

  DURING A DUAL PROCEDURE FOR AF, THE PROCEDURE WAS NOT COMPLETED. IT WAS NOTED THAT THE COOL POINT PUMP REMAINED AT 13 ML/MIN AFTER THE LESION. IN ORDER TO RESOLVE THE ISSUE, ANOTHER LESION WAS PERFORMED, WHICH STOPPED THE COOL POINT PUMP, AND THEN WHEN ANOTHER LESION WAS PERFORMED WITH THE CATHETER, THE PUMP STARTED FUNCTIONING AGAIN. THE ISSUE OCCURRED MULTIPLE TIMES THROUGHOUT THE PROCEDURE. ADDITIONALLY, IT WAS NOTED THAT AFTER ANOTHER LESION, THE MESSAGE "PEDAL DEPRESSED" WAS DISPLAYED, EVEN THOUGH THE PHYSICIAN'S FOOT WAS NOT ON IT. AFTER THIS, ENERGY WAS SWITCHED FROM RF TO PFA TO PERFORM THE NEXT LESION. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115994 ↗
• MalfunctionApr 29, 2026Device Emits Odor; Noise, Audible

  THIS REPORT IS TO ADVISE OF THERMAL DAMAGE THAT WAS NOTED DURING ANALYSIS. DURING THE PFA PROCEDURE WITHOUT DISCONNECTING OR MOVING ANYTHING, THE CURRENT PFA GENERATOR, SUDDENLY MADE A LOUD SOUND AND TURNED OFF. WHEN THIS HAPPENED, UPON TURNING IT BACK ON, THE SCREEN TO ACCESS THE CASE WAS GRAYED OUT AND INACCESSIBLE. THE GENERATOR WAS RESTARTED SEVERAL TIMES, CONNECTING AND DISCONNECTING EVERYTHING, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS CONTINUED USING CRYOABLATION FROM A NON-ABBOTT SYSTEM WITHOUT ANY FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028840 ↗
• MalfunctionApr 16, 2026Thermal Decomposition of Device

  THIS REPORT IS TO ADVISE OF THERMAL DAMAGE FOUND ON THE DEVICE DURING ANALYSIS. DURING A PFA PROCEDURE, IT WAS NOTED THAT THE CURRENT PFA GENERATOR BROKE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899545 ↗
• MalfunctionApr 1, 2026Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE USING THE VOLT PFA SYSTEM AND THE TACTIFLEX DUO CATHETER, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE PFA APPLICATIONS WERE APPLIED AS NORMAL, HOWEVER, WHEN SWITCHING TO RF, THE IMPEDANCE APPEARED OUT OF RANGE AND RF APPLICATION STOPPED. TROUBLESHOOTING INCLUDED REPLACING THE AMPERE GENERATOR, REBOOTING BOTH THE AMPERE GENERATOR AND THE CURRENT GENERATOR, EXCHANGING THE CATHETERS, AND EXCHANGING THE RF NEUTRAL PATCH, BUT THE ISSUE PERSISTED. IT WAS SUSPECTED THAT THE CURRENT GENERATOR WAS CAUSING THE ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754303 ↗
• MalfunctionMar 31, 2026Communication or Transmission Problem

  DURING THE PFA PROCEDURE, THERE WAS A PROCEDURAL DELAY DUE TO A CURRENT GENERATOR ISSUE. THE AMPERE DID NOT DISPLAY ANY IMPEDANCE VALUES. THE CATHETER WAS REPLACED AND THE AMPERE GENERATOR WAS REPLACED WITH NO RESOLUTION. THE CURRENT GENERATOR WAS TURNED OFF WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED USING RADIOFREQUENCY. THE CURRENT GENERATOR WILL BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745984 ↗
• MalfunctionMar 8, 2026Fire; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER FINISHING ABLATION OF THE LEFT PULMONARY VEINS AND ABOUT TO REACH FOR THE RIGHT PULMONARY VEINS, A LOUD BANG WAS HEARD AND A FLAME AND SPARKS WERE OBSERVED FROM THE FOOTSWITCH PORT. A MESSAGE WAS NOTED, "PFA GENERATOR FAULT. HARDWARE ISSUE DETECTED. SELECT RESTART TO RESTART THE PFA GENERATOR." THE PROCEDURE WAS CHANGED TO RF TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541763 ↗
• MalfunctionMar 4, 2026Communication or Transmission Problem

  DURING THE PROCEDURE, THE PROCEDURE WAS CANCELED DUE TO A GENERATOR ISSUE. THE CURRENT GENERATOR INITIALLY TURNED ON AND CONNECTED CORRECTLY TO THE ENSITE SYSTEM AND DISPLAYED CORRECTLY. JUST PRIOR TO GAINING ACCESS INTO THE PATIENT, WHEN THE HDMI CABLE WAS PLUGGED INTO THE CURRENT GENERATOR, IT WOULD NOT DISPLAY WITH AN ERROR STATING "NO VIDEO OUTPUT." MULTIPLE DIFFERENT SCREENS WERE TRIED WITH NO RESOLUTION. THE CURRENT GENERATOR WAS TURNED OFF AND LEFT FOR 5-10 MINUTES AND MULTIPLE START UP PROCESSES WERE TRIED. THE LAPTOP PLUGGED INTO THE MAIN SCREEN ON THE CURRENT WHICH DISPLAYED FINE. THERE WERE GREEN LIGHTS ON BOTH THE SCREEN, REMOTE SCREEN, AND CURRENT AMPLIFIER INDEPENDENTLY BUT WHEN ANY SCREEN PLUGGED INTO THE CURRENT GENERATOR, THE GREEN LIGHT BEGAN TO FLASH AND SAY ¿NO VIDEO OUTPUT¿. THE ISSUE WAS UNABLE TO BE RESOLVED AND THE PROCEDURE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512482 ↗
• MalfunctionMar 4, 2026Signal Artifact/Noise; Output Problem

  DURING THE PULSED FIELD ABLATION ATRIAL FIBRILLATION PROCEDURE, THERE WAS A PROCEDURAL DELAY DUE TO A GENERATOR ISSUE. WHEN STARTING THE ABLATION, THE CAPACITORS WERE CHARGED AND PFA WAS APPLIED AS NORMAL TO THE LEFT VEINS. HOWEVER, WHEN MOVING TO THE LOWER RIGHT VEIN, TWO SUCCESSFUL APPLICATIONS WERE APPLIED, BUT ON THE THIRD AN ERROR MESSAGE APPEARED. THE ERROR MESSAGE SAID "PFA GENERATOR FAULT" AND "ELECTRICAL SHORT CIRCUIT IN THERAPY PATHWAY DETECTED." THE GUIDEWIRE WAS CHECKED AND IT WAS NOT TOUCHING ANY ELECTRODE, THE BALLOON WAS REPOSITIONED AND PULLED SLIGHTLY BACK, AND THE PFA WAS APPLIED AGAIN, BUT THE SAME ERROR MESSAGE APPEARED. "HARDWARE CHECK FAILED" ALSO APPEARED. THE CURRENT GENERATOR WAS RESTARTED, BUT WHEN TRYING TO OPEN A CASE, IT WAS NOT ABLE TO BE OPENED. THE GENERATOR WAS RESTARTED SEVERAL TIMES, THE CASE CONNECTED TO THE ENSITE X SYSTEM AND IN STANDALONE MODE WAS OPENED, THE GENERATOR WAS RESTARTED WITH NOTHING CONNECTED, THEN THE GENERATOR RESTARTED WITH JUST THE POWER SUPPLY CONNECTED, THE POWER SUPPLY WAS PLUGGED INTO DIFFERENT OUTLETS, AND THE ENSITE X SYSTEM WAS RESTARTED, BUT THE ISSUE PERSISTED. IN TOTAL, THE CURRENT GENERATOR WAS RESTARTED AROUND 15 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507688 ↗
• MalfunctionMar 2, 2026Output Problem

  DURING A VOLT PROCEDURE, TWO ERRORS OCCURRED WITH THE CURRENT PFA GENERATOR DISPLAYED TWO ERRORS RESULTING IN A 30 MINUTE DELAY,¿ MISSPINNING 1-8 AND 9-10¿ AND HARDWARE ISSUE¿ PFA GENERATOR FAULT¿. THE MESSAGES APPEARED DURING AND AFTER MULTIPLE ABLATION APPLICATIONS. THE SYSTEM WAS RESTARTED 4-5 TIMES, THE CABLES WERE DISCONNECTED, AND THE CATHETER WAS EXCHANGED, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CONTINUED WITH CRYO AND FINISHED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24487348 ↗