EnSite™ EE3000 (UDI 05415067014573)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05415067014573), received between Oct 14, 2019 and Nov 8, 2024 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Power Problem; Power Problem

  ADDITIONAL INFORMATION CONFIRMED THIS EVENT OCCURRED DURING DEVICE PREPARATION WITHOUT INVOLVING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646278 ↗
• MalfunctionJun 27, 2024Failure to Power Up; Failure to Power Up

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A FAILURE TO POWER UP ISSUE WITH THE ENSITE VELOCITY DISPLAY WORKSTATION THAT RESULTED IN A CANCELLATION OF THE PROCEDURE. WHEN THE PATIENT WAS LYING ON THE HOSPITAL BED, IT WAS NOTED THAT THE ENSITE DISPLAY WORKSTATION COULD NOT BE TURNED ON NORMALLY. REPEATED REBOOTS WERE INEFFECTIVE AND THE POWER BUTTON ON THE ENSITE VELOCITY DISPLAY WORKSTATION FLASHED RED. THERE WAS NO SPARE MACHINE, AND THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS PERFORMED FOR THE SAME PATIENT THE FOLLOWING DAY AND WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623779 ↗
• MalfunctionApr 9, 2024Power Problem; Power Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, POWER ISSUES RESULTED IN A PROCEDURAL DELAY. THREE MINUTES AFTER CONNECTING THE EQUIPMENT AND TURNING ON THE COMPUTER, THE COMPUTER SUDDENLY LOST POWER. AFTER CHECKING THAT THE POWER CONNECTION WAS NORMAL, IT RESTARTED AGAIN. THE POWER WAS LOST AGAIN DURING STARTUP, IT WAS NOTED THE POWER SUPPLY WAS NOT WELL CONNECTED. THE ISSUE WAS NOT SOLVED AFTER MULTIPLE ATTEMPTS. AFTER THE COMPUTER WAS TURNED ON, THREE MINUTES AFTER ENTERING THE CASE, THE SCREEN FROZE AND THE MOUSE AND OTHER KEYBOARDS BECAME UNRESPONSIVE. THE MEMORY STICK WAS REMOVED, AND AFTER SHUTTING DOWN AND RESTARTING SEVERAL TIMES, IT STARTED NORMALLY AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE TROUBLESHOOTING OCCURRED OVER AN HOUR AND A HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072143 ↗
• MalfunctionNov 27, 2023Failure to Power Up; Failure to Power Up

  DURING AN ATRIAL FIBRILLATION PROCEDURE, POWER ISSUES WITH THE DWS RESULTED IN CANCELLATION OF THE PROCEDURE. THE POWER BUTTON OF THE COMPUTER HOST SHOWED A RED LIGHT AND RESTARTING THE COMPUTER MULTIPLE TIMES DID NOT RESOLVE THE ISSUE. IT WAS DECIDED TO CANCEL THE PROCEDURE AND USED NON-ABBOTT EQUIPMENT TO COMPLETE THE PROCEDURE LATER THAT SAME DAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209393 ↗
• MalfunctionJul 25, 2023Failure to Power Up; Failure to Power Up

  DURING A PAROXYSMAL ATRIAL FIBRILLATION, THE ENSITE VELOCITY DISPLAY WORKSTATION COMPUTER WOULD NOT TURN ON WHICH RESULTED IN A DELAY OF 3 HOURS. THE CONNECTIONS WERE CHECKED AND THE ENSITE VELOCITY DISPLAY WORKSTATION COMPUTER WAS RESTARTED WHICH DID NOT RESOLVE THE ISSUE. THE ENSITE VELOCITY DISPLAY WORKSTATION COMPUTER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389812 ↗
• MalfunctionJul 11, 2023Power Problem; Power Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE SYSTEM WAS UNABLE TO ENTER THE MENU SELECTION MODE AND RESTARTING WAS INVALID CAUSING A DELAY. ANOTHER SYSTEM WAS OBTAINED FROM A DIFFERENT HOSPITAL WHICH TOOK 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298846 ↗
• MalfunctionMar 30, 2023Unexpected Shutdown; Unexpected Shutdown

  DURING A PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, AN ERROR OCCURRED WITH THE ENSITE VELOCITY DISPLAY WORKSTATION RESULTING IN DELAY. THE ENSITE VELOCITY DISPLAY WORKSTATION WAS TURNED ON WHEN THE CASE WAS STARTED. AFTER A MOVEMENT OF THE PATIENT TABLE, THE IMAGE WAS LOST ON THE SCREEN. THE CONNECTIONS WERE CHECKED, BUT THE IMAGE WAS DID NOT APPEAR. THE ENSITE VELOCITY DISPLAY WORKSTATION WAS RESTARTED, AND AN ERROR SCREEN APPEARED " 929- FATAL MCA ERROR." THE ENSITE VELOCITY DISPLAY WORKSTATION WAS TURNED OFF AGAIN, RECHECKED THE CONNECTIONS, AND TURNED BACK ON, AND THE SYSTEM STARTED NORMALLY, AND THE CASE CONTINUED. AFTER APPROXIMATELY 2 HOURS, THE SCREEN SIGNAL WAS LOST AGAIN AND THE ENSITE VELOCITY DISPLAY WORKSTATION WAS RESTARTED AGAIN, BUT THE SAME ERROR APPEARED. AT THIS TIME, THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES, AND NO FURTHER TROUBLESHOOTING WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649132 ↗
• MalfunctionFeb 28, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  DURING PREPARATION FOR THE PULMONARY VEIN ISOLATION PROCEDURE, MONITOR DISPLAY ISSUES OCCURRED RESULTING IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED PRIOR TO THE START OF THE PROCEDURE THAT THE MONITOR WAS FLICKERING. THE FIBER WAS REPLACED, WENT DIRECTLY WITH A CABLE BUT THE ISSUE WAS NOT RESOLVED. IT WAS THOUGHT THAT THE ISSUE WAS EITHER DP TO DVI ADAPTER OR VIDEO CARD BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454466 ↗
• MalfunctionFeb 15, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE SVT PROCEDURE, IT WAS NOTED THAT THE VERTICAL SCREEN PROMPTED THAT THE 1920 * 1200 RESOLUTION COULD NOT BE SUPPORTED WHICH CAUSED DELAYS TO TREATMENT. AFTER RESTARTING THE HOST COMPUTER, BOTH DISPLAYS WOULD NOT DISPLAY NORMALLY. AFTER PLUGGING AND UNPLUGGING THE GRAPHICS CARD, MEMORY MODULE AND HARD DISK, THE ISSUE STILL DID NOT RESOLVE. AFTER REPLACING THE STANDBY HOST COMPUTER AND MONITOR, THE ISSUE WAS RESOLVED AND THE OPERATION PROCEEDED NORMALLY. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378385 ↗
• MalfunctionDec 16, 2021Computer Software Problem; Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch; Computer Software Problem; Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch

  POST PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. DURING THE PULMONARY VEIN ISOLATION PROCEDURE, THE WORKSTATION/DISPLAY FROZE. THE DWS WAS RESTARTED AND THE STUDY RESUMED, BUT THERE WAS NO AUTOMARK, THEREFORE, THE PROCEDURE CONTINUED WITHOUT AUTOMARK. FOLLOWING THE PROCEDURE, WHEN PERFORMING AN ECHOCARDIOGRAM, AN EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 13017383 ↗
• MalfunctionOct 11, 2021Erratic or Intermittent Display; Display or Visual Feedback Problem; Communication or Transmission Problem; Failure of Device to Self-Test; Erratic or Intermittent Display; Display or Visual Feedback Problem; Communication or Transmission Problem; Failure of Device to Self-Test

  DURING THE PROCEDURE, COMMUNICATION, DISPLAY AND STARTUP ISSUES WERE NOTED AND THE PROCEDURE WAS CANCELLED. THE AMPLIFIER WAS SWITCHED OFF AND ON AGAIN, WHICH DID NOT RESOLVE THE ISSUE. THE POWER PLUG WAS DISCONNECTED FROM THE AMPLIFIER, SWITCHED OFF AND ON WITH THE POWER PLUG DISCONNECTED, CONNECTED THE POWER PLUG AGAIN AND SWITCHED THE AMPLIFIER ON, WHICH AGAIN DID NOT RESOLVE THE ISSUE. DISCONNECTING ALL THE PREVIOUS CONNECTIONS FROM THE AMPLIFIER (FIBER OPTIC, RECORDCONNECT, NAVLINK) DID NOT RESOLVE THE ISSUE. THE SAME ATTEMPTS WERE DONE AGAIN, AND THE CPU WAS SWITCHED OFF AND THE AMPLIFIER RESTARTED, AND THE LIGHT WAS SOLID GREEN. A NEW STUDY WAS OPENED, VALIDATED AND BEGAN MAPPING. A DELAY IN CATHETER MOVEMENT WAS NOTED, HOWEVER THE PROBLEM RESOLVED AFTER WAITING FOR TWO MINUTES WITHOUT DOING ANYTHING. AS THE ABLATION CATHETER WAS NOT YET AT THE TABLE, THE TACTISYS ICON IN THE RIGHT BOTTOM PART OF THE SCREEN WAS DISCONNECTED (THE ICON WAS GREEN AFTER VALIDATION). ANATOMY OF THE RIGHT ATRIUM WAS PERFORMED WITH THE CS CATHETER. WHEN THE ABLATION CATHETER WAS ABOUT TO BE INSERTED, THE TACTISYS WAS CONNECTED AGAIN BY CLICKING THE ICON IN THE RIGHT BOTTOM PART OF THE SCREEN. THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12604817 ↗
• MalfunctionJul 21, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN ATRIAL FIBRILLATION ABLATION (AF) PROCEDURE, THE CATHETERS WERE CONSISTENTLY DRIFTING WHILE HAVING A WAVE-LIKE MOTION WHICH CAUSED A SIGNIFICANT DELAY. FOLLOWING ADVANCEMENT INTO THE LEFT ATRIUM, THE CATHETER HAD A WAVE-LIKE MOTION TO IT. THE CATHETER WAS EXCHANGED AND THE SAME ISSUE WAS NOTED. TROUBLESHOOTING INCLUDED THE DISABLING MAGNETICS, SWAPPING THE TACTISYS, GENERATOR, ALL CABLES, AND MULTIPLE SYSTEM REBOOTS WERE PERFORMED. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS AN AF ABLATION, BUT ONLY CTI ABLATION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206414 ↗
• MalfunctionJul 6, 2021Application Program Problem; Application Program Problem

  DURING AN AV-NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, AFTER VIDEO RETURNED TO THE REMOTE MONITOR, WHILE A FEW MINUTES INTO THE CASE, THE COMPUTER FROZE. IT WAS NOTED THAT ONLY BASIC DATA ENTRY WAS BEING PERFORMED AT THE TIME AND NO MAPPING WAS BEING PERFORMED. THE SYSTEM WAS PLUGGED INTO A NORMAL AC OUTLET. A HARD REBOOT OF THE DWS WAS DONE. UPON REBOOT, NO ERRORS APPEARED, HOWEVER, THE PC FROZE FOR A SECOND TIME AND ANOTHER REBOOT WAS PERFORMED. ONCE REBOOTED, THE PC WAS ABLE TO FUNCTION BUT WAS SLOW/LAGGING. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. A DELAY OCCURRED DUE TO THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120636 ↗
• MalfunctionMay 13, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING A PULMONARY VEIN CONTRACTION PROCEDURE, THERE WAS A DELAY OF 5 OR 6 SECONDS BETWEEN CATHETER MOVEMENT AND ITS REPRESENTATION IN NAVX. IT WAS QUESTIONED WHETHER THE MEMORY WAS FULL ON THE CPU SO THE STUDY WAS ENDED, SOME STUDIES WERE DELETED AND THE STUDY WAS RESUMED AGAIN. THE ISSUE REMAINED, SO IT WAS DECIDED TO DELETE MORE STUDIES, BUT THEN IT WAS NOTE THAT THERE WERE 247 GB FREE IN THE CPU, SO THE CPU AND AMPLIFIER WERE RESTARTED WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820653 ↗
• MalfunctionMar 4, 2021No Display/Image; No Display/Image

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2021-00089, 2184149-2021-00043. DURING AN A-FLUTTER ABLATION PROCEDURE, THE AMPLIFIER WOULD BLINK YELLOW WHEN COMING ON ABLATION. THE AMPLIFIER ERROR MESSAGE "LOGOUT AND RESTART AMPLIFIER AND SYSTEM" WAS NOTED. THE DWS, GENERATOR AND AMPLIFIER WERE ALL POWER CYCLED BUT THE ISSUE REMAINED. THE CATHETER WAS REPLACED AND CRYO WAS USED TO CONTINUE THE PROCEDURE. UPON FURTHER INSPECTION, BENT PINS WERE NOTED ON THE NAVX CONNECTOR ON THE AMPLIFIER. IN ADDITION, THE ENSITE DWS SECONDARY MONITOR OUTPUT (VIA DISPLAY PORT) WAS NOT WORKING. THE SECONDARY IMAGE WAS UNABLE TO COME UP ON SIEMENS MONITOR. THE DISPLAY PORT DONGLE WAS REPLACED TWICE, IN ADDITION TO REPLACING THE DVI TO DVI CABLE, BUT THAT DID NOT RESOLVE THE ISSUE. THE SET UP WAS CONNECTED ON THE PRIMARY MONITOR PORT AND THE IMAGE WAS ABLE TO BE DISPLAYED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411018 ↗
• MalfunctionDec 29, 2020Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, THERE WAS A SHIFT ON THE MAPPING SYSTEM AND AN ERROR MESSAGE ON THE AMPERE, AND THE PROCEDURE WAS CANCELLED. AFTER SOME ABLATION HAD BEEN COMPLETED, THE TIP OF THE CATHETER APPEARED TO FLY OUT OF THE GEOMETRY ON ENSITE, AND THE ERROR MESSAGE " 'AMPLIFIER ERROR. LOG OUT AND POWER CYCLE BOTH VELOCITY DWS AND AMPLIFIER BEFORE RESTARTING. CONTACT SJM TECHNICAL SUPPORT." WAS DISPLAYED. THE CASE WAS CANCELLED, AND THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11091516 ↗
• InjurySep 14, 2020Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE WITH THE PATIENT ON THE TABLE, THE PATCH DID NOT APPEAR AS CONNECTED ON ENSITE. THE PATCHES WERE EXCHANGED TWICE AND THE NAVLINK WAS EXCHANGED WITH NO SUCCESS. THE CASE WAS ABANDONED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532435 ↗
• InjuryJun 22, 2020Application Program Problem; Application Program Problem

  DURING THE PROCEDURE, SLUGGISH PERFORMANCE OF CATHETER MOVEMENT WAS NOTED WITH AN APPROXIMATE 7 SECOND DELAY. THIS ISSUE OCCURRED SPORADICALLY THROUGHOUT THE PROCEDURE RESULTING IN A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY. FURTHER TROUBLESHOOTING WAS PERFORMED, AND ONCE THE MEDIA CONVERTER WAS REPLACED IT RESOLVED THE SLUGGISH PERFORMANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10179964 ↗
• InjuryFeb 27, 2020Failure to Power Up; Failure to Power Up

  PRIOR TO THE PROCEDURE, FOLLOWING PATIENT PREPARATION, THE CASE WAS CANCELLED DUE TO A COMPUTER STARTUP ISSUE. WHEN BOOTING THE PC, THE PC WOULD BEEP AND FLASH RED BUT NEVER FULLY START UP. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765843 ↗
• InjuryFeb 6, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2020-00073, 3008452825-2020-00066. DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A CANCELLATION, TAMPONADE AND SUBSEQUENT DEATH OCCURRED. THE CS CATHETER AND THE HIS CATHETER WERE INTRODUCED VIA THE FEMORAL VEIN INTO THE CORONARY SINUS AND AT THE HIS BUNDLE. DURING INTRODUCTION, EXCESSIVE CATHETER MOVEMENT WAS OBSERVED. A FLEXIBILITY WAS INTRODUCED VIA RETROGRADE ACCESS INTO THE AORTA, AND THE LATMAP AND A GEOMETRY OF THE LVOT WAS COLLECTED. SYSTEM REFERENCE AND RESPIRATION COMPENSATION WERE UTILIZED AND THE UPDATE RESPIRATION WAS OFF. ABLATION WAS STARTED AT THE EARLIEST POINT IN THE LVOT. DUE TO THE CATHETER MOVEMENT, THE CS 5 WAS UTILIZED FOR REFERENCE. FLOURO WAS NOT USED TO LOCATE THE CATHETERS FOLLOWING THE SHIFT. DURING PREPARATION OF CHANGING FROM ARTERIAL ACCESS TO VENOUS ACCESS THE PHYSICIAN NOTICED ABNORMAL STEERING OF THE FLEXIBILITY. FOLLOWING ABLATION IN THE LVOT, THERE WERE STILL PVCS. THE VISUALIZATION OF THE ABLATION CATHETER WAS NOT IN THE CORRECT LOCATION, AND SYSTEM REFERENCE WAS UTILIZED AND A SHIFT OCCURRED. THE CS SHADOW AND CURRENT CS POSITION WERE NOT ALIGNED. THE PHYSICIAN DECIDED TO GO IN RVOT AND A FLEXI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677256 ↗
• MalfunctionOct 14, 2019Sparking; Sparking

  PRIOR TO A PROCEDURE, THE POWER CONDITIONER POWER CABLE SPARKED WHEN SYSTEM WAS TURNED ON. THE CONDITIONER WAS REMOVED AND SYSTEM POWERED UP NORMALLY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187431 ↗