nGEN Pump D139702Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10846835017472), received between Jan 17, 2024 and Sep 25, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Failure to Pump” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (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. 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892659 ↗
• MalfunctionSep 23, 2026Mechanical Jam; No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873913 ↗
• MalfunctionSep 23, 2026Mechanical Jam; No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873877 ↗
• MalfunctionApr 29, 2026Communication or Transmission Problem; Unexpected Shutdown

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT-SIDE ATRIAL FLUTTER ABLATION PROCEDURE WITH A NGEN PUMP AND THE DEVICE REBOOTED ON ITS OWN. THE J&J REPRESENTATIVE ON SITE REPORTED THAT THE MESSAGE "PUMP NOT CONNECTED" WAS BEING DISPLAYED ON THE NGEN¿ MONITOR. THEY RESEATED THE CABLES WITHOUT RESOLUTION. THE THEY MANUALLY REBOOTED THE NGEN¿ GENERATOR AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032519 ↗
• MalfunctionMar 20, 2026Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND THE NGEN¿ PUMP POWER BOX "SPARKED" ABOUT THIRTY MINUTES AFTER IT WAS POWERED ON. THE NGEN¿ PUMP POWERED DOWN AND LOST POWER. THE POWER CABLE MELTED WHERE IT CONNECTED INTO THE POWER ADAPTER. NO OTHER EQUIPMENT WAS AFFECTED. THERE WAS NO PATIENT CONSEQUENCE. THEY DISCONNECTED THE POWER SUPPLY FROM THE OUTLET AND THE NGEN¿ PUMP ITSELF. NO OTHER DAMAGE WAS OBSERVED. ADDITIONAL INFORMATION INDICATED THAT NO CATHETER WAS BEING USED AND WAS NOT IN THE PROCEDURE. THERE WAS AN UNEXPECTED SMELL FROM THE EQUIPMENT LIKE BURNT ELECTRICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646945 ↗
• MalfunctionJul 7, 2025Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NGEN PUMP AND HIGH FLOW WOULD INTERMITTENTLY NOT GO ON. IT WAS REPORTED THAT WHEN ABLATING WITH THE QDOT CATHETER, THE FLUID FOR THE QDOT CATHETER WOULD INTERMITTENTLY NOT GO TO HIGH FLOW. THE TEMPERATURE WOULD RISE AND TITRATE THE POWER READINGS DISPLAYED ON THE NGEN MONITOR. THE QDOT CATHETER WAS RESEATED WITHOUT RESOLUTION. THE PRESETS WERE SWITCHED ON THE NGEN GENERATOR BUT THE ISSUE PERSISTED. THE REPORTER USED A DEFAULT PRESET FOR THE NGEN GENERATOR WITHOUT RESOLUTION. THE POWER SETTINGS WERE CHANGED FROM 40 TO 45 ON THE NGEN MONITOR BUT THE ISSUE PERSISTED. THE REPORTER STATED THAT WHEN THE ISSUE WAS NOTICED, THEY WOULD COME OFF ABLATION. WHEN COMING BACK ON ABLATION, THE ISSUE WOULD RESOLVE TEMPORARILY. THE PROCEDURE CONTINUED WITH THE ISSUE OCCURRING INTERMITTENTLY THROUGHOUT THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22419802 ↗
• MalfunctionJul 1, 2025Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NGEN PUMP AND HIGH FLOW WOULD INTERMITTENTLY NOT GO ON. IT WAS REPORTED THAT WHEN ABLATING WITH THE QDOT CATHETER, THE FLUID FOR THE QDOT CATHETER WOULD INTERMITTENTLY NOT GO TO HIGH FLOW, THE TEMPERATURE WOULD RISE AND TITRATE THE POWER READINGS DISPLAYED ON THE NGEN MONITOR. THE QDOT CATHETER WAS RESEATED WITHOUT RESOLUTION. THE PRESETS WERE SWITCHED ON THE NGEN GENERATOR BUT THE ISSUE PERSISTED. THE CALLER USED A DEFAULT PRESET FOR THE NGEN GENERATOR WITHOUT RESOLUTION. THE POWER SETTINGS WERE CHANGED FROM 40 TO 45 ON THE NGEN MONITOR BUT THE ISSUE PERSISTED. THE CALLER STATED THAT WHEN THE ISSUE WOULD BE NOTICED, THEY WOULD COME OFF ABLATION. THE CALLER STATED THAT WHEN COMING BACK ON ABLATION, THE ISSUE WOULD RESOLVE TEMPORARILY. THE PROCEDURE CONTINUED WITH THE ISSUE OCCURRING INTERMITTENTLY THROUGHOUT THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376480 ↗
• MalfunctionMay 19, 2025Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NGEN PUMP. WHEN RADIOFREQUENCY (RF) ENERGY WAS APPLIED TO THE QDOT MICRO CATHETER, THE POWER SETTING DID NOT CLIMB AS SUSPECTED. THEY REMOVED THE CATHETER, AND IT WAS FOUND THAT THE IRRIGATION WAS TURNED OFF TO THE CATHETER. THE IRRIGATION WAS TURNED BACK ON TO THE CATHETER AND IT IRRIGATED PROPERLY. THE CATHETER WAS REINSERTED AND WHEN RF ENERGY WAS APPLIED, THE POWER SETTINGS PERFORMED AS SUSPECTED. THERE WAS NO INDICATION FROM THE NGEN PUMP (NO ERROR/ALERT) THAT THE CATHETER WAS NOT IRRIGATING PROPERLY. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041786 ↗
• MalfunctionDec 23, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRYO ATRIAL FIBRILLATION PROCEDURE WITH AN NGEN PUMP. THE BUBBLE DETECTOR ON THE NGEN PUMP WAS NOT BEEPING WHEN BUBBLES WERE PRESENT DURING THE HIGH FLOW FLASHING AND ON HIGH FLOW NORMAL MODE. THEY WERE ABLE TO FLUSH OUT ALL THE BUBBLES AND CONTINUE WITH THE CASE WITHOUT ANY ISSUES. 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 21001706 ↗
• MalfunctionJul 15, 2024Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH A NGEN PUMP AND MULTIPLE TIMES DURING THE PROCEDURE, WHILE ABLATING THE LEFT ATRIUM, THE NGEN WOULD CUT OFF ABLATION. AN ERROR "HIGH FLOW MISMATCH" WAS DISPLAYED ON THE NGEN. THEY HAD TO RESTART WITH A NEW LESION TO CONTINUE USING THE FOOT PEDAL. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747028 ↗
• MalfunctionJun 25, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A NGEN PUMP AND THERE WERE BUBBLES IN THE IRRIGATION TUBING DURING THE PROCEDURE THAT WERE NOTICED BY THE PHYSICIAN BUT THE NGEN PUMP NEVER ALERTED THAT THERE WERE BUBBLES DETECTED. THE TUBING WAS FLUSHED AND THE TUBING AND THE PUMP SENSOR "LOOKED GOOD". WHEN BUBBLES WERE NOTICED, THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND FLUSHED. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605828 ↗
• MalfunctionApr 19, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A NGEN PUMP AND AFTER FAST FLUSHING THE PUMP, IT WILL NOT GO TO THE LOW FLOW SETTING. THE ISSUE WAS RESOLVED BY REBOOTING THE PUMP BY UNPLUGGING AND REPLUGGING AND/OR DOING A POWER CYCLE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146801 ↗
• MalfunctionApr 19, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A NGEN PUMP, US CONFIGURATION AND THE MEDICAL TEAM EXPERIENCED AN ON-GOING LOW FLOW SETTING ISSUE. AFTER FAST FLUSHING THE PUMP, IT WILL NOT GO TO THE LOW FLOW SETTING. THE ISSUE WOULD BE RESOLVED ONLY AFTER REBOOTING THE PUMP BY UNPLUGGING AND REPLUGGING AND/OR DOING A POWER CYCLE. THE MEDICAL TEAM WAS ABLE TO CLEAR EVERY INSTANCE OF THIS ISSUE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145070 ↗
• MalfunctionApr 12, 2024Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NGEN PUMP AND WHEN THE PHYSICIAN WOULD IMMEDIATELY COME BACK ON RADIOFREQUENCY (RF) DURING THE 4 SECONDS POST, THE FLOW RATES WERE NOT AUTOMATICALLY ADJUSTED. THEY WILL LOWER THE POST FOR A SECOND TIME TO CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19099622 ↗
• MalfunctionApr 2, 2024Decreased Pump Speed; Decreased Pump Speed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WHICH INCLUDED A NGEN PUMP AND THE LOW FLUID WARNING FAILED ON THE PUMP. THEY WERE NOT RECEIVING A LOW FLUID WARNING WHEN THE BAG REACHED BELOW THE 100 ML LEVEL. THE EQUIPMENT ALLOWED ABLATION WHEN THE ISSUE OCCURRED. THERE WAS NO ERROR OR WARNING MESSAGE ABOUT THE FLUID LEVEL ON EITHER THE NGEN MONITOR OR THE CARTO WORKSTATION. THERE WAS A BUBBLE DETECTED ERROR BY THE PUMP WHICH LED THEM TO REALIZE THE LOW FLUID LEVEL. THE CORRECT CATHETER SETTING WAS SELECTED, AND THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. IRRIGATION PUMP SETUP WAS AUTOMATIC. THE NGEN GENERATOR WAS BEING USED IN POWER-CONTROLLED MODE. NO TROUBLESHOOTING WAS PERFORMED. THEY REPLACED AND RESET THE BAG; HOWEVER, THEY DID NOT GO BELOW THE THRESHOLD AGAIN. THE ISSUE REMAINED UNRESOLVED. THEY DECLINED ANY SERVICE OR REPAIR FOLLOW-UP. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028505 ↗
• MalfunctionMar 5, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NGEN PUMP, US CONFIGURATION AND BUBBLES WERE DISCOVERED IN THE TUBING. DURING THE STUDY, IT WAS NOTICED THAT BUBBLES WERE COMING THROUGH THE TUBING. THE TUBING WAS FLUSHED AND THE ISSUE DID NOT RESOLVE. THE ABLATION CATHETER WAS REPLACED AND THE ISSUE DID NOT RESOLVE. THE PATIENT¿S VITALS REMAINED STEADY BUT THE PATIENT HAS NOT AWAKENED YET. IT IS UNKNOWN IS THE PATIENT HAS ANY SYMPTOMS AT THIS TIME. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION AND ADDITIONAL INFORMATION ABOUT THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837772 ↗
• MalfunctionJan 17, 2024Fire; Improper or Incorrect Procedure or Method; Communication or Transmission Problem; Fire; Improper or Incorrect Procedure or Method; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A NGEN PUMP AND A FIRE ISSUE OCCURRED. IT WAS REPORTED THAT SALINE SOLUTION GOT ON THE NGEN PUMP AC ADAPTER AND THE AC ADAPTER CAUGHT ON FIRE. THE NGEN CONSOLE TO PUMP CABLE WAS "FRIED," DUE TO THE FIRE, AND THERE WAS BLACK RESIDUE ALL OVER THE CABLE. THE AC ADAPTER WAS REPLACED, THE NGEN CONSOLE TO PUMP CABLE WAS REPLACED, AND THE SALINE DRIP WAS MOVED AWAY FROM THE POWER CABLES. THE PROCEDURE CONTINUED. THE NGEN COMPONENTS HAVE BEEN REMOVED FROM USE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 19-DEC-2023. THERE WAS A FIRE IN THE LAB. THE FIRE FLARED UP AFTER THE FIRST APPLICATION, ORIGINATING FROM THE NGEN PUMP'S POWER SUPPLY, WHICH WAS SOAKED WITH SALINE FROM A SPILLED SALINE BAG. THE PROCEDURE WAS FINISHED. THERE WAS NO IMPACT ON THE PATIENT. THERE WAS NO ISSUE WITH NGEN PUMP AND TRUPULSE GENERATOR. BOTH WERE WORKABLE AFTER THEY CHANGED THE POWER SUPPLY CABLE WHICH WAS BURNED. THE SALINE LEAKED FROM THE BAG AND THE LIQUID WAS ON TOP OF THE POWER CABLE OF NGEN PUMP. THAT LIQUID MET WITH AN ELECTRIC CURRENT AND CAUSED FIRE. THEY COULD NOT CHECK THE SALINE BAG AND TUBING SET BECAUSE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526956 ↗

Recalls under the same FDA submission

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

• Z-0058-2018 · Sep 6, 2017 · Terminated
  THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
• 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-1328-04 · Jul 16, 2004 · Terminated
  Stockert 70 Radio Frequency Ablation Generator