Ampere™ H700488Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 05415067004888), received between Jun 11, 2018 and Jan 27, 2026 — classified as 25 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (15 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Communication or Transmission Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA AND TYPICAL ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, THE TACHYCARDIA WAS ABANDONED DUE TO A RECOGNITION ISSUE. THE AMPERE WOULD NOT CONNECT TO THE COOL POINT PUMP. THE AMPERE WAS POWER CYCLED AND THE CABLE WAS REPLACED WITH NO RESOLUTION. THE AMPERE WOULD ALSO NO RECOGNIZE THE CATHETERS. THE ISSUE COULD NOT BE RESOLVED AND THE PROCEDURE NOT COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188690 ↗
• MalfunctionDec 2, 2025Failure to Power Up; Failure to Power Up

  DURING PATIENT PREPARATION FOR A PROCEDURE, IT WAS NOTED THAT THE AMPERE GENERATOR WOULD NOT BOOT UP. THE PROCEDURE WAS THEN CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698433 ↗
• MalfunctionAug 4, 2025High impedance; High impedance

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS AN IMPEDANCE ISSUE WITH THE GENERATOR RESULTING IN A DELAY. WHEN ATTEMPTING TO DELIVER RF ENERGY WITH THE ABLATION CATHETER, THE IMPENDENCE WOULD JUMP FROM MID 80¿S TO GREATER THAN 250OHMS AND COULD NOT DELIVER THERAPY. THE IMPENDENCE PADS WERE REPOSITIONED AND THEN REPLACED, AND THE CATHETER WAS EXCHANGED WITH NO RESOLVE. THE GENERATOR WAS THEN EXCHANGED WHICH ALLOWED FOR RF ENERGY TO BE DELIVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702401 ↗
• MalfunctionJul 16, 2025Low impedance; Impedance Problem; Low impedance; Impedance Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURES, THE IMPEDANCE VALUE OF THE TACTIFLEX WAS TOO LOW AS IT KEPT GIVING A 999 ERROR. TROUBLESHOOTING WAS PERFORMED WHICH DID NOT RESOLVE THE ISSUE AND THE CASE WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519572 ↗
• MalfunctionMay 23, 2025Impedance Problem; Impedance Problem

  DURING AN ATRIAL FIBRILLATION / ATRIAL FLUTTER PROCEDURE, OPTICAL AND IMPEDANCE ISSUES OCCURRED, AND THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT THE CONTACT FORCE VALUES WOULD INTERMITTENTLY GO IN AND OUT. THE CATHETER WAS REPLACED WHICH SEEMED TO RESOLVE THE ISSUE, BUT THEN CONTACT FORCE VALUES APPEARED INCORRECT. IT WAS ALSO REPORTED THAT THE IMPEDANCE VALUE ON THE AMPERE GENERATOR WAS DISPLAYED AS 999. A THIRD CATHETER WAS INTRODUCED, AND THE TACTIFLEX RF CABLE WAS REPLACED, BUT THE ISSUE PERSISTED, AND THE PROCEDURE WAS ABANDONED. IT WAS UNKNOWN AS TO WHETHER THE TACTISYS OR THE AMPERE GENERATOR CAUSED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078086 ↗
• MalfunctionApr 29, 2025Failure to Deliver Energy; Failure to Deliver Energy

  DRING AN ATRIAL FLUTTER PROCEDURE, THE AMPERE GENERATOR WAS NOT GENERATING ANY WATTAGE. THE CATHETER WAS EXCHANGED, AND THE CABLES WERE RECONNECTED WITHOUT RESOLVE. THE PROCEDURE WAS THEN CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928697 ↗
• MalfunctionMar 21, 2025Failure to Deliver Energy; Failure to Deliver Energy

  TWO HOURS AFTER STARTING A PROCEDURE, IT WAS NOTED THAT THE GENERATOR WAS NOT DELIVERING ANY POWER. THE GENERATOR WAS RESET AND THE ISSUE WAS RESOLVED. WHEN THIS WAS ENCOUNTERED, THE PHYSICIAN WONDERED IF POWER WAS DELIVERED DURING THE PREVIOUS CASE. WHEN THE PARAMETERS OF THE LAST CASE WERE REVIEWED, IT WAS CONFIRMED THAT THERE WASN'T ANY POWER DELIVERED AT ANY TIME DURING THE 61 ABLATIONS THAT WERE AUTOMARKED, WHICH MEANS THE WHOLE FIRST CASE WAS MEANINGLESS. DURING THE FIRST PROCEDURE, THERE WERE NO ISSUES NOTED WITH THE GENERATOR AND NO ERROR MESSAGES. NO ONE NOTICED IF THE POWER WAS GOING UP OR DOWN ON THE GENERATOR SCREEN. AT THE BEGINNING OF THE PROCEDURE THE ARRHYTHMIA WAS EASILY INDUCIBLE (AVNRT) AND AT THE END OF THE CASE THEY WERE UNABLE TO REINDUCE THE ARRHYTHMIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667681 ↗
• MalfunctionJan 14, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. WHEN THE ABLATION CATHETER WAS PLUGGED INTO THE ENSITE X SYSTEM, POLE #2 WAS DISTORTED ON THE ENSITE X SYSTEM AND THERE WAS NO EGM ON THE ENSITE X OR THE RECORDING SYSTEM. THE CATHETER AND THE ABLATION CABLE WERE REPLACED, BUT THE ISSUE PERSISTED. THE AMPERE GENERATOR CABLE WAS ALSO REPLACED, BUT THE ISSUE PERSISTED. THE GENERATOR WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148754 ↗
• MalfunctionJul 1, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE AMPERE GENERATOR, RESULTING IN CANCELLATION OF THE PROCEDURE. WHEN THE SAPPHIRE CATHETER WAS CONNECTED, THE AMPERE GENERATOR SHOWED "CATHETER NOT CONNECTED" AND THERE WERE NO SIGNALS OR GEOMETRY ON THE ENSITE PRECISION SYSTEM. TWO DIFFERENT CATHETERS, AND THREE DIFFERENT CATHETER CONNECTION CABLES WERE TRIED. THE FIBER TO ENSITE PRECISION DISPLAY WORKSTATION WAS CHECKED, BUT THE ISSUE PERSISTED. THE AMPERE GENERATOR WAS CONNECTED TO THE ENSITE PRECISION SYSTEM. THERE WAS NOT A BACKUP AMPERE GENERATOR AT THE SITE, SO THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645643 ↗
• MalfunctionOct 16, 2023Output Problem; Output Problem

  DURING AN ATRIOVENTRICULAR NODE ABLATION PROCEDURE, OUTPUT ISSUES REQUIRING TROUBLESHOOTING MEASURES RESULTED IN A PROCEDURAL DELAY. THE GENERATOR AND CATHETER WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE ABLATION CATHETER WAS INSERTED INTO THE PATIENT BUT AN ERROR MESSAGE ON THE AMPERE GENERATOR READ "GENERATOR MALFUNCTION" AND THEN READ "CATHETER NOT CONNECTED". THE CABLE WAS REPLACED TWICE, AND THE CATHETER WAS EXCHANGED. THE AMPERE WAS REBOOTED, BUT THE ERROR MESSAGE REMAINED. AFTER TROUBLESHOOTING, IT WAS DETERMINED THAT THE ISSUE WAS WITH THE AMPERE. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT (BIOSENSE WEBSTER) GENERATOR AND CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941614 ↗
• MalfunctionMay 17, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES WITH THE GENERATOR RESULTED IN A SIGNIFICANT PROCEDURAL DELAY. THE GENERATOR WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE ABLATION CATHETER AND THE MAPPING CATHETER WERE IN PLACE INSIDE THE HEART AND JUST BEFORE THE RF DELIVERY WAS TO BE PERFORMED, AN ERROR MESSAGE OF "PUMP NOT CONNECTED" SUDDENLY DISPLAYED AND THE RF DELIVERY COULD NOT BE PERFORMED BY THE ABLATION CATHETER. THERE WERE NO ISSUES WITH THE WAVEFORM OR CATHETER DISPLAY IN ENSITE. THE COOL POINT PUMP AND THE IRRIGATION PUMP COMMUNICATION CABLE WERE REPLACED, BUT WITH NO RESOLUTION. THE COOL POINT PUMP WAS REPLACED, BUT WITH NO RESOLUTION. THE AMPERE GENERATOR WAS REPLACED WITH A DEVICE THAT WAS NOT ON SITE RESULTING IN A 1.5 HOUR DELAY WHILE GETTING THE REPLACEMENT DEVICE. THE ISSUE WAS RESOLVED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948269 ↗
• MalfunctionMar 24, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN AV NODE ABLATION PROCEDURE, THE GENERATOR DISPLAYED A "NO CATHETER CONNECTED" MESSAGE WAS DISPLAYED FOR BOTH A THERAPY CATHETER AND A TACTICATH CATHETER WHICH CAUSED PROCEDURAL DELAYS. THE GENERATOR WAS REPLACED WITH A GENERATOR FROM ANOTHER FACILITY TO RESOLVE THE ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610119 ↗
• MalfunctionMar 8, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING ABLATION DURING AN ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES BETWEEN THE ENSITE X AND THE AMPERE GENERATOR RESULTED IN THE CANCELLATION OF THE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ENSITE X LOST COMMUNICATION WITH AMPERE GENERATOR. THE PATIENT WAS PREPPED, INTUBATED, AND THE TRANSEPTAL PUNCTURE HAD BEEN PERFORMED. WHEN THE SMALL FORM FACTOR PLUGGABLE (SFP) WAS RESEATED, COMMUNICATION APPEARED TO BE RESTORED. IT WAS NOTED THAT THE CABLE HAS NEEDED TO BE RESEATED MULTIPLE TIMES IN LAST FEW CASES. THE PROCEDURE WAS CANCELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501904 ↗
• MalfunctionMar 6, 2023Impedance Problem; Impedance Problem

  DURING AN AV NODE ABLATION, IMPEDANCE ISSUES WITH THE CATHETERS AND THE GENERATOR RESULTED IN PROCEDURAL DELAYS. THE DEVICES WERE EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING THE PROCEDURE, WHEN USING THE SAFIRE CATHETER WITH THE AMPERE GENERATOR, THE BASELINE IMPEDANCE WAS 124 OHMS BUT WHEN ENERGY WAS TURNED ON, THE IMPEDANCE WENT TO 999 AND SHUT OFF. THE AMPERE GENERATOR WAS SET TO 29W, TEMPERATURE 40C, AND AN IMPEDANCE LIMIT OF 165 OHMS AND 60 SECONDS. AN ALERT "IMPEDANCE OUT OF RANGE" WAS NOTED. THE SAFIRE CATHETER WAS EXCHANGED FOR A FLEXABILITY CATHETER AND THE SAME ISSUE OCCURRED. THE FLEXABILITY CATHETER WAS REPLACED BY A NON-ABBOTT CATHETER (BIOSENSE) AND THE AMPERE GENERATOR WAS REPLACED WITH A NON-ABBOTT GENERATOR (BIOSENSE) AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16489209 ↗
• MalfunctionDec 5, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN AF PROCEDURE, THE POSITIONAL INFORMATION DISPLAY ON THE TACTICATH SE WAS UNUSUAL AND UNABLE TO BE USE CLINICALLY. THE GEOMETRY AND MAPPING WERE PERFORMED WITH OTHER CATHETERS WITHOUT ISSUE, HOWEVER IT WAS NOT MOVING ON THE ENSITE SIDE WHEN THE TACTICATH SE WAS INSERTED INTO THE HEART. THE CATHETER WAS EXCHANGED, THE RESPIRATORY CORRECTION WAS RETAKEN, REVALIDATED, ALL DEVICES INCLUDING THE DWS, AMPLIFIER, AND AMPERE GENERATOR, WERE POWER CYCLED, CONNECTIONS WERE RECHECKED, BUT THE ISSUE PERSISTED. THE AMPERE GENERATOR WAS REPLACED WITH A NON-ABBOTT PRODUCT AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING INSPECTION AT NIHON KOHDEN TSURUGASHIMA OFFICE AFTER RETURNING FROM THE MEDICAL FACILITY, THE RECORDING SYSTEM WAS USED TO CONFIRM THE ISSUE, BUT THE REPORTED ISSUE WAS NOT REPRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15917779 ↗
• MalfunctionJul 12, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CASE WAS CANCELLED DURING PATIENT PREPARATION DUE TO A COMMUNICATION ISSUE WITH THE AMPERE GENERATOR. REBOOTING THE AMPERE GENERATOR WOULD TEMPORARILY RESOLVE THE ISSUE, BUT THEN IT WOULD DISCONNECT AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14990537 ↗
• MalfunctionApr 15, 2022Impedance Problem; Impedance Problem

  RELATED MANUFACTURING REF: 2184149-2022-00104, 2184149-2022-00105. DURING AN ATRIOVENTRICULAR NODAL REENTRANT CASE, THE USER SWITCHED FROM CRYO TO RF AND RECEIVED A 999-IMPEDANCE ERROR ON THE GENERATOR. PATCH PLACEMENT WAS CONFIRMED AND REPLACED WITH GOOD COMMUNICATION BETWEEN THE GENERATOR AND AMPLIFIER. THE CABLES WERE INSPECTED, RESEATED, REBOOTED THE AMPLIFIER, GENERATOR, TACTISYS AND THE DWS WHICH DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REPLACED WITH ONE FROM A DIFFERENT LOT AND ATTEMPTED A SECOND SE PORT, BUT THE ISSUE REMAINED. THE CASE CONTINUED BY SWITCHING BACK TO CRYO WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118078 ↗
• MalfunctionMar 23, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  DURING THE SLOW PATHWAY ABLATION, THE AMPERE GENERATOR WOULD NOT COMMUNICATE WITH THE FOOTSWITCH WHICH CAUSED A DELAY. A BACKUP FOOTSWITCH WAS TRIED, BUT THE ISSUE DID NOT RESOLVE. SWAPPING THE AMPERE RESOLVED THE ISSUE, WHILE USING THE ORIGINAL FOOTSWITCH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870244 ↗
• MalfunctionJan 31, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIOVENTRICULAR NODE ABLATION CASE, THE OUTPUT OF THE AMPERE GENERATOR DISPLAYED AS 0 AND TROUBLESHOOTING CAUSED A DELAY. REPLACING THE CATHETER AND THE GROUNDING PADS DID NOT RESOLVE THE ISSUE. THE GENERATOR WAS EXCHANGED AND THE CASE WAS COMPLETED WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392632 ↗
• MalfunctionOct 27, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  FOLLOWING THE PROCEDURE, AN OUTLET CABLE THAT WAS PLUGGED INTO AN OUTLET WAS CONNECTED TO THE GENERATOR GROUNDING PORT AND THE METAL INSIDE BECAME BURNT. THERE WERE NO ADVERSE CONSEQUENCES TO THE USER WHO CONNECTED THE OUTLET CABLE INTO THE GENERATOR GROUNDING PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704763 ↗
• MalfunctionOct 20, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, IT WAS NOT POSSIBLE TO ESTABLISH A CONNECTION WITH THE AMPERE GENERATOR AND THE PROCEDURE HAD TO BE CANCELLED. THE RADIOFREQUENCY CABLE WAS EXCHANGED, BUT THE ISSUE REMAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12664937 ↗
• MalfunctionSep 30, 2021Device Emits Odor; Unexpected Shutdown; Device Emits Odor; Unexpected Shutdown

  DURING A RE-DO ATRIAL FIBRILLATION PROCEDURE, A PROCEDURE DELAY OCCURRED. THE AMPERE SUDDENLY SHUTDOWN WHILE TACHYCARDIA WAS INDUCED AFTER ABLATION A BURNING SMELL WAS NOTED FROM THE AMPERE. THE POWER CABLE WAS REPLACED, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS DELAYED ONE HOUR UNTIL A REPLACEMENT UNIT WAS ABLE TO BE FOUND AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12553634 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, AFTER LEAVING THE PROCEDURE ROOM, A BURN WAS NOTED AT THE SITE WHERE A NON-ABBOTT DISPERSIVE PATCH WAS PLACED. IT IS UNKNOWN WHETHER THE PATCH WAS FIRMLY ATTACHED DURING THE PROCEDURE. DURING THE BEGINNING OF THE PROCEDURE, AFTER SEDATION, THE PATIENT COMPLAINED OF PAIN, BUT THE PROCEDURE WAS CONTINUED. AT THE BEGINNING OF THE ABLATION, THE IMPEDANCE WAS INDICATED 180 OHMS; SO THE UPPER IMPEDANCE SETTING VALUE WAS CHANGED FROM 150 OHMS TO 190 OHMS. THE PROCEDURE WAS CONTINUED AND COMPLETED. THE PATIENT WAS OUT FROM THE PROCEDURE ROOM AND RETURNED TO THE PATIENT ROOM.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 12511764 ↗
• MalfunctionSep 10, 2021High impedance; Communication or Transmission Problem; High impedance; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA (ATRIOVENTRICULAR REENTRANT TACHYCARDIA) PROCEDURE, AN "IMPEDANCE OUT OF RANGE" ERROR WAS NOTED ON THE GENERATOR WITH AN ALARM WHEN ATTEMPTING TO DELIVER RADIO FREQUENCY ENERGY, AND RF COULD NOT BE PERFORMED WHICH CAUSED A DELAY. THE CABLE BETWEEN THE CATHETER AND THE GENERATOR WAS RECONNECTED AND THE DISPERSIVE PATCHES WERE REATTACHED WITH NO RESOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453905 ↗
• MalfunctionAug 24, 2021High impedance; High impedance

  DURING ATRIAL TACHYCARDIA PROCEDURE, THE IMPEDANCE VALUE SHOWED AROUND 100 OHMS WITH NO TROUBLE WHEN THE CATHETER WAS INSERTED INTO THE HEART AND CONNECTED TO THE TACTISYS. THE IMPEDANCE VALUE WENT UP AROUND 250 OHMS ONCE THE RF ENERGY WAS DELIVERED. THE CATHETER TIP WAS CHECKED FOR BLOOD CLOTS WITH NONE FOUND. THE DISPERSIVE PAD WAS EXCHANGED. THE AMPERE GENERATOR WAS POWER-CYCLED WITH NO RESOLUTION. THE CATHETER WAS REPLACED TO A NEW ONE AND THE ABLATION STARTED. YET, THE REPORTED HIGH IMPEDANCE PROBLEM REMAINED. THE CATHETER WAS REPLACED TO A NON-ABBOTT CATHETER AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES ONTO THE PATIENT. A DELAY IN PROCEDURE OCCURRED DUE TO THIS ISSUE. AFTER THE PROCEDURE, THE AMPERE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358535 ↗