AmpereRecalls & reported problems across all models

We found 3 models of Ampere by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Jan 27, 2026 — classified as 28 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ampere problems

Ampere models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ampere™ H700488

  Cardiac ablation percutaneous catheter
  54 reports
• Ampere™ H700494

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  5 reports
• Ampere™ Remote Control

  Cardiac ablation percutaneous catheter
  2 reports

Recent Ampere adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 5, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THE AMPERE GENERATOR WAS UNABLE TO CONNECT TO THE ENSITE X. ATTEMPTED MULTIPLE REBOOTS, RESEATED CONNECTIONS, REBOOTED THE ENTIRE SYSTEM, AND STARTED A NEW STUDY WITH NO RESOLVE. REPLACED THE AMPERE FIBER, THE AMPERE, THE AMPLIFIER, AND IT WAS STILL NOT POSSIBLE TO CONNECT THE AMPERE TO THE ENSITE X. THE AMPERE REMOTE WAS REMOVED, AND THE AMPERE CONNECTED. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841865 ↗
• 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 ↗
• MalfunctionJun 1, 2023High impedance; High impedance

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, HIGH IMPEDANCE WAS NOTED WHICH CAUSED A DELAY. HIGH IMPEDANCE WAS NOTED ON THE CATHETER BEFORE RF. WHEN ABLATION STARTED, A HIGH IMPEDANCE ERROR OCCURRED. THE ABLATION CATHETER AND GROUNDING PADS WERE EXCHANGED WHICH DID NOT RESOLVED THE ISSUE. ADDITIONALLY, THE TACTISYS TO AMPERE RF CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE AMPERE GENERATOR WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039747 ↗
• 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 ↗
• MalfunctionMay 9, 2023High impedance; High impedance

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, IMPEDANCE ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THAT THERE WAS HIGH IMPEDANCE (ABOVE 150 OHMS) DURING ABLATION. THE RF CABLES AND CATHETER WERE EXCHANGED, BUT THE ISSUE PERSISTED AND THE PROCEDURE WAS CANCELLED. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900083 ↗
• 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 ↗

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