EnSite™ Velocity™ 100014514Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 05414734210713), received between Jun 26, 2018 and Mar 18, 2026 — classified as 39 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (28 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Communication or Transmission Problem

  DURING THE PROCEDURE, THE PROCEDURE WAS CANCELED DUE TO COMMUNICATION ISSUES. WITH THE PATIENT PREPARED, THERE WAS AN ERROR MESSAGE SAYING "LEFT LEG PATCH NOT RECOGNIZED" AND THE PATCHES WOULD NOT VALIDATE. WHEN THE ERROR MESSAGE APPEARED, IT DID NOT TRANSMIT CATHETER MOVEMENT. THE PATCHES WERE REPLACED, AND A NEW NAVLINK PATCH BOX WAS USED, BUT THE ISSUE WAS NOT RESOLVED. IT IS ALLEGED THAT THE COMMUNICATION ISSUE WAS DUE TO THE ENSITE VELOCITY AMPLIFIER. THE PROCEDURE WAS UNABLE TO BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628404 ↗
• MalfunctionFeb 26, 2026Electromagnetic Interference

  DURING A RF ATRIAL FIBRILLATION PROCEDURE, WHEN USING THE ENSITE VELOCITY AMPLIFIER, DISTORTION OF THE ABLATION CATHETER WAS OBSERVED RESULTING IN CANCELLATION OF THE PROCEDURE. TRANSSEPTAL PUNCTURE AND MAPPING OF THE LEFT ATRIUM HAD BEEN COMPLETED. TROUBLESHOOTING INCLUDED REPLACING THE AMPERE GENERATOR, GENCONNECT CABLE, AND GROUNDING PATCH, BUT THE ISSUE PERSISTED. IT WAS NOTED THAT THE GROUNDING PATCH WAS ABOVE THE SYSTEM REFERENCE, AND THE AMPERE GENERATOR WAS PLUGGED INTO THE SAME CIRCUIT FOR POWER. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465374 ↗
• MalfunctionNov 23, 2025Material Twisted/Bent; Material Twisted/Bent

  DURING AN ATRIAL FIBRILLATION PROCEDURE, MATERIAL INTEGRITY ISSUES WITH THE AMPLIFIER RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE DISTAL ELECTRODE OF THE ABLATION CATHETER HAD DISPLAYED ABNORMAL IMAGING AND NO POTENTIAL WAS DISPLAYED. UPON FURTHER INSPECTION, IT WAS FOUND THAT THE BLACK INTERFACE OF THE ENSITE VELOCITY AMPLIFIER HAD A DAMAGED PIN. THE ISSUE WAS RESOLVED BY USING A MOBILE PROTOTYPE FROM ANOTHER CENTER AS A SUBSTITUTE. PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627574 ↗
• MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, AFTER CATHETERS WERE INSERTED IN THE PATIENT, A BENT PIN WAS FOUND ON THE ENSITE AMPLIFIER RESULTING IN CANCELLATION OF THE PROCEDURE. WHEN ATTEMPTING TO VALIDATE, IT WAS NOTED THAT THERE WAS AN AMPLIFIER ERROR THAT MENTIONED A PATCH IMPEDANCE ERROR. THE PATCH PLACEMENT WAS VERIFIED AND IT WAS NOTED THAT THERE WAS A PATCH THAT WAS NOT GLUED ON CORRECTLY. THE PATCH WAS REPLACED, BUT THE ERROR MESSAGE PERSISTED. THE PHYSICAL STATUS OF THE NAVLINK WAS VERIFIED, BUT THE ISSUE PERSISTED. UPON INSPECTION, IT WAS NOTED THAT THERE WAS A DAMAGED PIN ON THE ENSITE AMPLIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496847 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  DURING THE SVT PROCEDURE, DISTORTION ISSUES RESULTED IN A PROCEDURAL DELAY. DISTORTION WAS OBSERVED ON THE ABLATION CATHETER. THE CATHETER AND CABLES WERE REPLACED BUT THE ISSUE WAS NOT RESOLVED. IT WAS NOTICED THAT THERE WERE BENT PINS ON THE ABLATION PORT ON THE AMPLIFIER. THE AMPLIFIER WAS REPLACED TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457675 ↗
• MalfunctionNov 12, 2024Communication or Transmission Problem; Communication or Transmission Problem

  AT THE START OF THE VENTRICULAR EXTRA SYSTOLE OF THE RVOT PROCEDURE, THE ENSITE VELOCITY AMPLIFIER WAS NOT CONNECTING WITH THE DWS. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE HAS BEEN RESCHEDULED FOR A DIFFERENT DATE. THE ISSUE WAS LATER RESOLVED AFTER UPGRADING THE FIRMWARE OF THE AMPLIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664231 ↗
• MalfunctionSep 23, 2024Output Problem; Output Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, THERE WAS AN OUTPUT ISSUE ON THE AMPLIFIER WHICH RESULTED IN A DELAY TO THE PROCEDURE. ON THE ENSITE PRECISION SYSTEM, THE ERROR MESSAGE "AMPLIFIER ERROR. LOG OUT AND POWER CYCLE BOTH THE ENSITE VELOCITY DWS AND AMPLIFIER BEFORE RESTARTING. CONTACT SJM TECHNICAL SUPPORT" APPEARED SEVERAL TIMES. BOTH THE AMPLIFIER AND DWS WERE RESTARTED ABOUT 7-8 TIMES. THE PROCEDURE WAS COMPLETED AFTER SEVERAL RESTARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20283441 ↗
• MalfunctionSep 6, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PROCEDURE, THERE WAS A NOISE ISSUE ON THE ABLATION CHANNEL DUE TO THE VELOCITY AMPLIFIER RESULTING IN CANCELLATION OF THE PROCEDURE. INSTEAD OF 50HZ/20MS IT SHOWED AS 8-10MS. WHEN ABLATING, THE SIGNAL WOULD BECOME UNREADABLE. THE PROCEDURE WAS STOPPED DUE TO RISK OF AN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157081 ↗
• MalfunctionAug 14, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING DEVICE PREPARATION FOR A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE AMPLIFIER WOULD NOT POWER UP CORRECTLY RESULTING IN A CANCELLATION OF PROCEDURE. IT WAS NOTED THAT THE AMPLIFIER WOULD NOT BOOT TO GREEN. THE AMPLIFIER WAS REBOOTED MULTIPLE TIMES, THE POWER CABLES AND FIBER OPTIC CABLES WERE REPLACED, BUT THE ISSUE WAS NOT RESOLVED. IT WAS ATTEMPTED TO BOOT UP THE AMPLIFIER WITH NO OTHER CONNECTIONS OTHER THAN THE POWER CABLE, BUT THE AMPLIFIER WOULD NOT BOOT TO GREEN. THE PATIENT WAS ON THE TABLE AND INTUBATED WHEN THE ISSUE OCCURRED. THE PATIENT HAD TO BE EXTUBATED AND TAKEN OFF THE TABLE. NO PROCEDURE WAS PERFORMED, AND NO ADVERSE EVENTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986368 ↗
• MalfunctionJul 18, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA, THERE WAS DISTORTION DUE TO THE ENSITE VELOCITY SYSTEM NAVLINK AND ENSITE VELOCITY AMPLIFIER, RESULTING IN CANCELLATION OF THE PROCEDURE. DISTORTION WAS OBSERVED ON ALL FOUR CATHETERS USED DURING THE PROCEDURE. THE PRECISION ELECTRODE KIT WAS CORRECTLY PLACED AND CONNECTED. ALL CABLES AND CONNECTIONS TO THE EP MAPPING AND RECORDING SYSTEMS WERE EXCHANGED. THE PROCEDURE WAS STOPPED BECAUSE IT WAS NOT POSSIBLE TO CONTINUE DUE TO THE DISTORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19775017 ↗
• MalfunctionJul 1, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE AMPLIFIER DURING ABLATION RESULTING IN CANCELLATION OF THE PROCEDURE. THERE WAS AN AMPLIFIER ERROR MESSAGE THAT THE FIBER OPTIC CONNECTION TO THE DISPLAY WORKSTATION WAS NOT FUNCTIONING. THERE WAS NOT A SOLID GREEN LIGHT AFTER REBOOTING THE AMPLIFIER. TWO REBOOTS BETWEEN THE DISPLAY WORKSTATION AND THE AMPLIFIER WERE ATTEMPTED, BUT THE ISSUE PERSISTED. DIFFERENT FIBER OPTIC CONNECTIONS FROM THE AMPLIFIER TO DISPLAY WORKSTATION DID NOT RESOLVE THE ISSUE EITHER. THE PROCEDURE WAS THEN CANCELLED WITH ONLY THREE FOURTHS OF THE VEINS ISOLATED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652318 ↗
• MalfunctionMar 18, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIAL TACHYCARDIA PROCEDURE, OUTPUT ISSUES RESULTED IN A PROCEDURAL DELAY. THE ABLATION CATHETER WAS USED FOR MAPPING AND ABLATION OF A FOCAL TACHYARRHYTHMIA. TWO MAPPING CATHETERS WERE ALSO USED FOR ARRHYTHMIA MAPPING AND REFERENCE. ALL CATHETERS WERE CORRECTLY CONNECTED TO THE ENSITE EQUIPMENT AND TO THE NON-ABBOTT POLYGRAPH (CARDIOTEK). FIRST, THE TWO MAPPING CATHETERS WERE INSERTED INTO THE PATIENT. ONE CATHETER WAS PLACED AS AN ELECTROGRAM REFERENCE AND THE OTHER WAS USED TO MAP THE ARRHYTHMIA WITHIN THE RIGHT ATRIUM AND SUPERIOR AND INFERIOR VENA CAVA, AND THE MAPPING WAS PERFORMED WITH COMPLETE FLUIDITY AND COLLECTION OF POINTS SUFFICIENT TO IDENTIFY THE SITE THAT TRIGGERED THE ARRHYTHMIA. THE ABLATION CATHETER WAS THEN INSERTED AND AS SOON AS IT WAS INSERTED, THE MOVEMENT INSIDE THE CAVITY WAS EXCESSIVE, SO MUCH SO THAT AFTER COLLECTING RESPIRATION THERE WAS NO DIRECTION IN THE MOVEMENT OF THE CATHETER OR ITS STABILITY, MAKING MAPPING DIFFICULT. ABLATION. THIS WAS VERIFIED WITH FLUOROSCOPY TO VERIFY THAT THE CATHETER WAS IN THE CORRECT POSITION BUT IN THE 3D PROJECTION IT DID NOT APPEAR STABLE. THE CATHETER WAS CONFIGURED AS INTENDED WITH ITS REFERENCE MODEL AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924173 ↗
• MalfunctionJan 29, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  PRIOR TO A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH THE PATIENT PREPPED, THE ENSITE AMPLIFIER DID NOT PASS THE POWER-ON SELF-TEST AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595140 ↗
• MalfunctionJan 19, 2024Signal Artifact/Noise; Signal Artifact/Noise

  THIS REPORT INCLUDES A CORRECTED PMA/510(K) NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547719 ↗
• MalfunctionJan 4, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS AN ANTERIOR PATCH DISCONNECTED ERROR. THE ISSUE WAS UNABLE TO BE RESOLVED AND THE PROCEDURE WAS CANCELLED AS A RESULT OF THE ISSUE. AFTER THE PROCEDURE, THE AMPLIFIER WAS REPLACED, AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441633 ↗
• MalfunctionDec 19, 2023Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING THE ATRIAL FIBRILLATION PROCEDURE, SELF-TEST FAILURE ISSUES WITH THE AMPLIFIER REQUIRED MULTIPLE TROUBLESHOOTING MEASURES WHICH DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED. IT WAS NOTED THAT THE AMPLIFIER BOOTED UP AND CONNECTED TO THE DWS WITHOUT ISSUE, HOWEVER, AFTER A FEW MOMENTS, THE AMPLIFIER STATUS LIGHT WENT TO SOLID AMBER. THE AMPLIFIER WAS REBOOTED SEVERAL TIMES, ALL CONNECTIONS WERE UNPLUGGED, THE POWER WAS UNPLUGGED AND LET SIT FOR A MINUTE ALL WITHOUT RESOLUTION. REBOOTED AGAIN TO SOLID AMBER AND IT REMAINED SOLID AMBER. THE CASE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357998 ↗
• MalfunctionNov 1, 2023Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING PREP FOR AN ATRIAL FIBRILLATION PROCEDURE WITH THE PATIENT ON THE TABLE, A SELF TEST ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. WHILE ASSEMBLING THE MACHINE, THE AMPLIFIER DID NOT START PROPERLY AND AN ORANGE LIGHT WAS DISPLAYED. MULTIPLE RESTARTS DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT. THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046444 ↗
• MalfunctionOct 30, 2023Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING THE ATYPICAL FLUTTER PROCEDURE, SELF-TEST ISSUES WITH THE AMPLIFIER REQUIRED MULTIPLE TROUBLESHOOTING MEASURES WHICH RESULTED IN A PROCEDURAL DELAY. THE AMPLIFIER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT WAS ON THE TABLE UNDER GENERAL ANESTHESIA AND CATHETERS WERE IN PLACE, BUT WHEN THE AMPLIFIER WAS TURNED ON, IT WOULD NOT PASS THE AUTOMATIC SELF-TEST, THERE WAS A FLASHING ORANGE LIGHT. THE AMPLIFIER WAS TURNED ON AND OFF MULTIPLE TIMES WITHOUT RESOLUTION. THE DELAY TO THE PROCEDURE WAS APPROXIMATELY 2 HOURS. THE AMPLIFIER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030250 ↗
• MalfunctionSep 19, 2023Power Problem; Power Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE AMPLIFIER DID NOT START PROPERLY AND THE PROCEDURE WAS CANCELLED. MULTIPLE RESTARTS DID NOT RESOLVE THE ISSUE WHICH RESULTED IN THE PROCEDURE BEING CANCELLED. THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774195 ↗
• MalfunctionJul 27, 2023Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE AMPLIFIER WAS FLASHING AMBER RESULTING IN CANCELLATION OF THE ATRIAL FIBRILLATION ABLATION. THE AMPLIFIER WAS REBOOTED SEVERAL TIMES AND WAS ABLE TO REBOOT UP TO SOLID GREEN. AFTER ABOUT 10 MINUTES, THE STATUS LIGHT CHANGED BACK TO AMBER. IT WAS ATTEMPTED TO DISCONNECT ALL CONNECTIONS AND POWERED IT OFF FOR A FEW MINUTES. THE AMPLIFIER WAS THEN REBOOTED TO GREEN BUT CHANGED BACK TO FLASHING AMBER. THE ATRIAL FIBRILLATION ABLATION WAS THEN STOPPED, AND THE PROCEDURE WAS CONTINUED AND COMPLETED ON WITH FLUTTER LINE USING X-RAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411001 ↗
• MalfunctionApr 28, 2023Material Twisted/Bent; Material Twisted/Bent

  DURING THE PROCEDURE WHILE PREPPING THE ABLATION CATHETER FOR A CTI FLUTTER ABLATION, ELECTRODE 2 WAS NOT SHOWING SIGNAL WHICH CAUSED A DELAY. THE CABLE WAS EXCHANGED FROM THE TACTISYS TO THE GENERATOR, THE BLACK CABLE FROM THE AMPERE TO THE AMPLIFIER WAS EXCHANGED, A DIFFERENT TACTISYS WAS USED AS WELL AS A DIFFERENT AMPERE. NONE OF THESE REMEDIED THE PROBLEM. ANOTHER ABLATION CATHETER WAS OBTAINED WHICH HAD THE SAME ISSUE. THE PINS IN THE ENSITE AMPLIFIER WERE THEN CHECKED WHERE THE BLACK CABLE PLUGS INTO, AND A BENT PIN WAS FOUND. THE HOSPITAL HAS A SECOND ENSITE AMPLIFIER, WHICH WAS HOOKED IT UP. THE CATHETER CAME UP AS IT SHOULD AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16837337 ↗
• MalfunctionFeb 8, 2023Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING DEVICE PREPARATION, WITH THE PATIENT ON THE TABLE, THE ENSITE AMPLIFIER DID NOT PASS THE SELF-TEST AND THE PROCEDURE WAS CANCELLED. EVEN IF IT SUCCEEDED AND THE LAMP WAS GREEN, IT BLINKED ORANGE AFTER A FEW SECONDS. TROUBLESHOOTING INVOLVED CHECKING ALL CONNECTIONS SEVERAL TIMES, RESTARTING THE AMPLIFIER AND THE DWS WITH AND WITHOUT CABLES SEVERAL TIMES AND CHECKING THE AIR FILTER, WHICH WAS CLEAN AND THE PROCEDURE WAS CANCELLED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327218 ↗
• MalfunctionJan 19, 2023Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING AN SVT PROCEDURE, WHEN THE AMPLIFIER WAS TURNED ON, IT WAS UNABLE TO TURN FROM YELLOW TO GREEN. THE CASE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16204102 ↗
• MalfunctionNov 17, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, A COMMUNICATION ISSUE OCCURRED, AND THE PROCEDURE WAS CANCELLED. FOLLOWING AN UPDATE TO A NEW CRYOCOUNCIL, TEMPERATURE SWINGS WERE NOTED ON THE THERMOCOUPLER. A SECOND REORDCONNECT AND SECOND AMPLIFIER WERE USED, HOWEVER, THE ISSUE PERSISTED, AND THE CASE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15812935 ↗
• MalfunctionNov 14, 2022Smoking; Smoking

  THERE WAS SMOKE COMING FROM THE AMPLIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15790253 ↗