EnSite™ ENSITE-SYSTEM-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067041722), received between Mar 15, 2022 and Jun 10, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Electromagnetic Interference; Electromagnetic Interference

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN ERROR MESSAGE WAS NOTED WHICH CAUSED A DELAY IN PROCEDURE. THE ENSITE X AMPLIFIER DID NOT PROVIDE MAGNETIC FIELD IN MULTIPLE INSTANCES. IN THE MIDDLE OF THE PROCEDURE, ALL CONNECTIONS DISAPPEARED BETWEEN THE DWS AND ENSITE X AMPLIFIER, AND THERE WAS AN ERROR MESSAGE STATING: "AMPLIFIER MAGNETIC FIELD ERROR". THE DWS AND ENSITE X AMPLIFIER WERE RESTARTED, THE FIELD FRAME AND ALL OTHER CABLES RECONNECTED, AND THE PROCEDURE CONTINUED FOR 5 MINUTES, HOWEVER THE SAME ERROR OCCURRED. THE SYSTEM WAS RESTARTED WITH A NEW CASE, BUT AFTER 15 MINUTES, THE SAME THING HAPPENED AGAIN. AFTER APPROXIMATELY 10 RESTARTS, THE DECISION WAS MADE TO CANCEL THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176662 ↗
• MalfunctionJan 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  RELATED MANUFACTURING REF: 3008452825-2024-00057, 2184149-2024-00022, 2184149-2024-00017. DURING AN ATRIAL FIBRILLATION PROCEDURE, THE 3RD PARTY NON-ABBOTT AMPLIFIER (PRUCKA 3.0) WOULD NOT PASS THE SELF-TEST, THE ENSITE X AMPLIFIER, ENSITE X RIGHT LEG PATCH, AND FIBER OPTIC CABLE EXPERIENCED COMMUNICATION ISSUES, AND THE ENSITE X SYSTEM COLOR MAPPING WAS NOT WORKING PROPERLY, RESULTING IN DELAY OF THE PROCEDURE. WHEN THE NAVIGATION MODE WAS CHANGED FROM NAVX MODE TO VOXEL MODE, IT WAS REPORTED THAT THE NON-ABBOTT AMPLIFIER (PRUCKA 3.0) ORANGE LED LIGHT BLINKED AND DID NOT TURN TO THE GREEN LIGHT. THE NON-ABBOTT AMPLIFIER (PRUCKA 3.0) WAS POWERED OFF AND ALL THE CABLES WERE DISCONNECTED FROM THE FRONT PANEL AND THEN RE-POWER ON, THEN IT WENT TO THE GREEN LIGHT. THE ENSITE X AMPLIFIER TO ENSITE X DISPLAY WORKSTATION COMMUNICATION ERROR CAME UP SEVERAL TIMES. IT WAS THEN ATTEMPTED TO RE-CONNECT THE LC CABLE WITH NO RESOLUTION. THE LC CABLE WAS THEN EXCHANGED, TEMPORARILY RESOLVING THE ISSUE. THERE WAS ALSO A FIELD FRAME GENERATOR COMMUNICATION ERROR THAT CAME UP. THE NON-ABBOTT AMPLIFIER (PRUCKA 3.0) AND FIELD FRAME GENERATOR WERE RE-CONNECTED AND REBOOTED SEVERAL TIMES AND THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585210 ↗
• MalfunctionMay 17, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  DURING A VENTRICULAR TACHYCARDIA (VT) PROCEDURE, A SELF-TEST ISSUE OCCURRED WHICH CAUSED A DELAY IN PROCEDURE. ENSITEX (2.0.1) WAS USED IN VOXEL MODE IN A PATIENT WITH A NON-ABBOTT HEART PUMP (IMPELLA). THE CONTACT FORCE (CF) ABLATION CATHETER WAS USED FOR MAPPING WITH CONTACT FORCE PRESENT. THE CF CATHETER WAS EXCHANGED FOR A DIAGNOSTIC CATHETER AND MAPPING WAS COMPLETED. THE USER WENT BACK TO THE CF CATHETER AND THERE WAS NO FORCE; JUST DASH LINES. TROUBLESHOOTING INCLUDED DISCONNECTING AND RECONNECTING THE CF CATHETER WITH NO RESOLUTION. THE CF CATHETER WAS REPLACED AND CONTACT FORCE WAS VISIBLE, BUT THE LIGHT WAS RED INDICATING THE SENSOR WAS BAD. ADDITIONALLY, THE ELECTRODES WERE RED AND MOVING DISJOINTEDLY. THE CF CATHETER WAS REPLACED WITH A DIFFERENT ABLATION CATHETER (FLEXABILITY) AND THE AMPLIFIER WAS RESTARTED WITH NO RESOLUTION. THE STUDY WAS THEN RESTARTED WHICH RESOLVED THE ISSUE. ABLATION WAS PERFORMED WITH THE FLEXABILITY AND THEN SWITCHED BACK TO USING A CF CATHETER, WHICH SHOWED CONTACT FORCE AND WAS VISUALIZED AS EXPECTED. AFTER ABLATING WITH THE CF CATHETER, ISSUES AROSE AGAIN WITH THE SENSOR BEING RED AND THE CATHETER MOVING. THE CASE WAS ABLE TO BE COMPLETED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946350 ↗
• MalfunctionApr 26, 2023Electromagnetic Interference; Electromagnetic Interference

  DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA (VT) PROCEDURE, THE ENSITEX SYSTEM EXPERIENCED METAL DISTORTION ISSUES AND THE CASE WAS CANCELLED. AT THE BEGINNING OF THE STUDY, THE METAL FIELD WAS CHECKED IN THE RECOMMENDED POSITION AND THERE WERE NO ISSUES. WHEN SETTING THE METAL BASELINE IN AP AT A WORKING HEIGHT, DISTORTION WAS ALREADY BEYOND 2. THE PHYSICIAN RAISED THE IMAGE INTENSIFIER SLIGHTLY AND SET THE METAL BASELINE AGAIN, WHICH SET THE DISTORTION THRESHOLD TO 1. THE PHYSICIAN WANTED TO BE PREPARED TO USE FLUOROSCOPY SINCE THIS WAS HIS FIRST VT WITH OUR SYSTEM. AS THE ABLATION CATHETER WAS BEING PLACED IN THE RIGHT ATRIUM, INITIAL GEOMETRY WAS COLLECTED WITH NO ISSUES. THE PHYSICIAN THEN WANTED TO REPROGRAM THE DEVICE SO HE PUT THE WAND IN THE FIELD TO DO SO. DURING THIS TIME THE METAL THRESHOLD WAS JUMPING BETWEEN 2-3 AND THE ABLATION CATHETER WAS SHAKING (THIS MAY BE NORMAL DUE TO THE WAND TEMPORARILY BEING OVER THE DEVICE). HOWEVER, ONCE THE WAND WAS REMOVED FROM THE FIELD, THE DISTORTION WAS STILL SITTING PAST 3. THE METAL BASELINE HAD TO BE RESET AND LOSE THE RA GEOMETRY AND PROCEEDED TO GO TRANSSEPTAL. AFTER TRANSSEPTAL, THE ABLATION CATHETER WAS PLACED IN THE LA AND GE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815240 ↗
• MalfunctionSep 9, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THERE WAS A DISPLAY ISSUE WITH THE CATHETER RESULTING IN CANCELLATION OF THE PROCEDURE. IT WAS BELIEVED TO BE A SOFTWARE ISSUE. IT WAS REPORTED THE ABLATION CATHETER APPEARED TO MISS-LOCATE WITHIN THE HEART COMPARED TO OTHER CATHETERS. THE TACTICATH SE CATHETER WAS BEING USED IN NAVX MODE. X-RAY WAS ATTEMPTED TO CONTINUE THE PROCEDURE, BUT IT WAS ULTIMATELY DECIDED TO END THE PROCEDURE AND THE PATIENT WAS STABLE. THE PROCEDURE HAS NOT BEEN RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396535 ↗
• MalfunctionJun 23, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH ENSITE X IN VOXEL MODE, A DISPLAY ISSUE OCCURRED WHICH CAUSED A DELAY. THE TACTICATH SE WAS CONNECTED TO THE AMPERE, THE ABLATION METRICS (IMPEDANCE, CURRENT, TEMPERATURE, POWER) WERE DISPLAYING CORRECTLY ON THE AMPERE AND CARDIOLAB SYSTEM, BUT NOT ON THE ENSITE X (DESPITE THE AMPERE SYMBOL ON THE ENSITE X SHOWING GREEN FOR A SUCCESSFUL CONNECTION MOST OF THE TIME). THEN IT INTERMITTENTLY FLASHED ORANGE WITH AN ERROR SAYING THE AMPERE WAS DISCONNECTED. A DIFFERENT FIBER CABLE WAS TRIED BETWEEN THE AMPERE AND THE ENSITE X, AS WELL AS POWER CYCLING THE AMPERE, BUT NEITHER RESOLVED THE ISSUE. AT THE END OF THE CASE, WE REBOOTED BOTH THE ENSITE X DWS AND THE AMPLIFIER, WHICH WAS APPEARED TO RESOLVE THE ISSUE AND THE CASE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787099 ↗
• MalfunctionMay 20, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE IN VOXEL MODE WITH THE PATIENT IN THE ROOM AND PREPPED, THE PRS-A WAS NOT VISUALIZED WITHIN ITS BOUNDING BOX WHICH IMPACTED THE ABILITY TO SEE THE HIS BUNDLE ELECTROGRAM DURING AVNRT ABLATION. THE PRS-A WAS MOVED AROUND THE PATIENT¿S CHEST AND A LOCATION COULD NOT BE FOUND THAT WOULD CONSISTENTLY STAY WITHIN THE PRS-A DETECTION BOX. THE CASE WAS CANCELLED RATHER THAN PROCEED IN NAVX MODE. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455517 ↗
• MalfunctionApr 11, 2022Output Problem; Output Problem

  DURING AN ATRIAL FLUTTER ABLATION (ABANDONED AND ELECTRICALLY CARDIOVERTED) PROCEDURE, THE ELECTRODES WERE RED, AND THEY WERE MOVING. THE BACK PATCH WAS NOTED TO BE WET WITH SWEAT, SO IT WAS REPLACED AND MOVED TO THE BELLY BUT THE ISSUE DID NOT RESOLVE AND THE CASE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT THE PROCEDURE HAS NOT BEEN RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14077097 ↗
• MalfunctionApr 5, 2022Electromagnetic Interference; Electromagnetic Interference

  DURING THE PROCEDURE WITH THE PATIENT PREPPED, METAL DISTORTION WAS NOTED AND THE CASE WAS CANCELLED. THE TABLE WAS ADJUSTED, THE C-ARM, MONITOR, IV POLES, CARTS AND BOOMS WERE MOVED. METAL DISTORTION WOULD LOWER WITH EVERYTHING MOVED AWAY, BUT INCREASED AFTER SEVERAL MINUTES WITH THE EQUIPMENT STILL MOVED AWAY. THE CASE WAS ABANDONED WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015613 ↗
• MalfunctionMar 15, 2022Erratic or Intermittent Display; Output Problem; Erratic or Intermittent Display; Output Problem

  DURING THE REDO ATRIAL FIBRILLATION OF POSTERIOR WALL ISOLATION AND ATYPICAL ATRIAL FLUTTER PROCEDURE, THE SYSTEM LOST THE MAPPING CATHETER LOCATION. DISCONNECTING, REMOVING, AND RECONNECTING THE CATHETER APPEARED TO SOLVE THE ISSUE INITIALLY, BUT LATER IN THE CASE WHEN A REDO OF THE MAP WAS ATTEMPTED, THE CATHETER LOCATION WAS LOST AND COULD NOT BE RESTORED. THE ISSUE WAS NOT RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13769966 ↗