EnSiteRecalls & reported problems across all models

We found 37 models of EnSite by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 318 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2018 and Sep 28, 2026 — classified as 25 injuries, 293 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (119 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 EnSite problems

EnSite models

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

• EnSite™ ENSITE-AMP-02

  Computer, diagnostic, programmable
  106 reports
• EnSite™ ENSITE-R-AMP-02

  Computer, diagnostic, programmable
  38 reports
• EnSite™ ENSITE-DWS-01

  Computer, diagnostic, programmable
  34 reports
• EnSite™ EE3000

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  21 reports
• EnSite™ ENSITE-DWS-1.1

  Computer, diagnostic, programmable
  17 reports
• EnSite™ ENSITE-FF-01

  Computer, diagnostic, programmable
  10 reports
• EnSite™ ENSITE-SRFLNK-01

  Computer, diagnostic, programmable
  10 reports
• EnSite™ ENSITE-SYSTEM-111

  Computer, diagnostic, programmable
  10 reports
• EnSite™ ENSITE-SEK-5-01

  Computer, diagnostic, programmable
  8 reports
• EnSite™ ENSITE-DWS-2.0.1

  Computer, diagnostic, programmable
  8 reports
• EnSite™ ENSITE-DWS-04

  Computer, diagnostic, programmable
  8 reports
• EnSite™ Velocity NavLink

  Computer, diagnostic, programmable
  5 reports
• EnSite™ ENSITE-SW-3.1

  Computer, diagnostic, programmable
  5 reports
• EnSite™ ENSITE-AMP-01

  Computer, diagnostic, programmable
  3 reports
• EnSite™ ENSITE-SW-3.1.1

  Computer, diagnostic, programmable
  3 reports
• EnSite™ EC1000

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 reports
• EnSite™ EE3000

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• EnSite™ ENSITE-FF-4.5C-01

  Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-PRSFRNT-01

  Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-ACBL-60-01

  Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-SW-2.0.1

  Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-SW-03

  Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-SW-3.0.2

  Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-DWS-3.1

  Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-SW-4.0.1

  Computer, diagnostic, programmable
  2 reports
• EnSite™ Velocity

  Computer, diagnostic, programmable
  1 report
• EnSite™ H421054

  Computer, diagnostic, programmable
  1 report
• EnSite™ Velocity ArrayLink

  Computer, diagnostic, programmable
  1 report
• EnSite™ A-ENS-MAGEXT-CBL

  CABLE, ELECTRODE
  1 report
• EnSite™ ENSITE-PRSBACK-01

  Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-ACBL-160-01

  Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-FF-ABRKT-01

  Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-R-DWS-1.1

  Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-SYSTEM-201

  Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-TFM-3.1

  Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-SW-05

  Computer, diagnostic, programmable
  1 report
• EnSite™ ENSITE-DWS-05

  Computer, diagnostic, programmable
  1 report

Recent EnSite adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Thermal Decomposition of Device

  During a procedure, a cancellation was noted when the EnSite X field frame was not being recognized by the system after connecting it. Disconnecting and reconnecting the field frame as well as restarting the EnSite X amplifier resolved the issue. It was also noted that after connecting the catheters to the amplifier, there was an "amplifier error, cannot communicate with amplifier" message and the catheters were repeated shown connected and then disconnected. Trying the catheters on different ports and restarting the EnSite X system di not resolve the issue and the catheters would only show up for a few seconds on the EnSite. Mapping was not possible and when ending the study, an "unexpected error" popup was shown. Resuming the procedure after rebooting the EnSite X DWS was not possible, and the procedure could not be finished as planned. Further checking found that the field frame connections against the connector looked charred. There were no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923770 ↗
• MalfunctionSep 25, 2026Installation-Related Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903368 ↗
• MalfunctionAug 17, 2026Output Problem

  During an atrial fibrillation procedure, after patches were placed on the patient, an attempt was made to create a new study using an existing patient record. At that time, the system displayed an "unexpected error" message, and the study could not be created. The EnSite X DWS was exchanged with a replacement system, resulting in a procedural delay. Following replacement of the DWS, the procedure was completed successfully with no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287646 ↗
• MalfunctionJul 27, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006224 ↗
• MalfunctionApr 30, 2026Failure of Device to Self-Test

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE USING RF, THE CORONARY SINUS CATHETER COULD NOT BE VISUALIZED RESULTING IN A DELAY. REBOOTING THE DWS GAVE COMMUNICATION ERRORS BETWEEN THE AMPLIFIER, DWS, AND FIELD FRAME CONNECTION. REBOOTING THE AMPLIFIER AGAIN RESULTED IN A FLASHING AMBER STATUS LIGHT. REBOOTING THE DWS AND AMPLIFIER FOR A 3RD TIME RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049900 ↗
• MalfunctionApr 23, 2026Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A PROCEDURAL DELAY DUE TO A COMMUNICATION ISSUE. AFTER THE PATIENT WAS DRAPED, VALIDATION WAS PERFORMED AND THE SYSTEM GENERATED A "VALIDATION SUCCEEDED" MESSAGE, QUICKLY FOLLOWED BY AN ERROR FOR A "LEFT LEG OR SYSTEM REFERENCE" ISSUE. WHEN LOOKING AT THE LOG FILES IT SHOWED A "LOOSE LEFT LEG PATCH". THE LEFT LEG PATCH WAS CHECKED AND APPLIED WELL. THE CONNECTION TO THE SURFACELINK WAS CHECKED TOO. VALIDATION WAS ATTEMPTED AGAIN BUT THE SAME ERROR MESSAGE AND AN IMPEDANCE ERROR MESSAGE ALSO APPEARED. THE LEFT LEG AND SYSTEM REFERENCE PATCHES WERE REPLACED AND A NEW STUDY WAS STARTED. VALIDATION WAS ATTEMPTED AGAIN WITH NO SUCCESS. THE SURFACELINK WAS REPLACED WITH NO RESOLUTION. THE AMPLIFIER WAS REPLACED WITH NO RESOLUTION EITHER. THE PATCHES WERE REPLACED AGAIN WITH A THIRD SET, THE DWS AND AMPLIFIER WERE REBOOTED, AND NEW STUDY WAS ALSO STARTED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966513 ↗
• MalfunctionApr 23, 2026Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A PROCEDURAL DELAY DUE TO A COMMUNICATION ISSUE. AFTER THE PATIENT WAS DRAPED, VALIDATION WAS PERFORMED AND THE SYSTEM GENERATED A "VALIDATION SUCCEEDED" MESSAGE, QUICKLY FOLLOWED BY AN ERROR FOR A "LEFT LEG OR SYSTEM REFERENCE" ISSUE. WHEN LOOKING AT THE LOG FILES IT SHOWED A "LOOSE LEFT LEG PATCH". THE LEFT LEG PATCH WAS CHECKED AND APPLIED WELL. THE CONNECTION TO THE SURFACE LINK WAS CHECKED TOO. VALIDATION WAS ATTEMPTED AGAIN BUT THE SAME ERROR MESSAGE AND AN IMPEDANCE ERROR MESSAGE ALSO APPEARED. THE LEFT LEG AND SYSTEM REFERENCE PATCHES WERE REPLACED AND A NEW STUDY WAS STARTED. VALIDATION WAS ATTEMPTED AGAIN WITH NO SUCCESS. THE SURFACE LINK WAS REPLACED WITH NO RESOLUTION. THE AMPLIFIER WAS REPLACED WITH NO RESOLUTION EITHER. THE PATCHES WERE REPLACED AGAIN WITH A THIRD SET, THE DWS AND AMPLIFIER WERE REBOOTED, AND NEW STUDY WAS ALSO STARTED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966500 ↗
• MalfunctionApr 16, 2026Signal Artifact/Noise

  DURING A TYPICAL AFL PROCEDURE, THERE WAS A PROCEDURAL DELAY. IT WAS NOTED THAT ALL OF THE ELECTRODES ON THE TACTIFLEX CATHETER HAD NOISE ON THEM, AND THE CATHETER APPEARED DISTORTED ON THE GUI. TROUBLESHOOTING INCLUDED REBOOTING, REPLACING THE TACTIFLEX CATHETER, REPLACING THE RF CABLES, REPLACING THE AMPERECONNECT CABLE, REPLACING THE AMPERE, AND REPLACING THE TACTISYS, BUT THE ISSUE PERSISTED. THE AMPLIFIER WAS REPLACED, AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899061 ↗
• MalfunctionApr 10, 2026Communication or Transmission Problem

  DURING THE PULSED FIELD ABLATION ATRIAL FIBRILLATION PROCEDURE, THERE WAS A PROCEDURAL DELAY. THERE WAS AN ISSUE INITIATING THE MAGNETICS. AN ATTEMPT WAS MADE TO REBOOT THE AMPLIFIER, BUT THE AMPLIFIER BOOTED TO A FLASHING ORANGE. TROUBLESHOOTING INCLUDED REBOOTING THE AMPLIFIER AGAIN AND DISCONNECTING ALL THE CABLES FROM THE FRONT OF THE AMPLIFIER, BUT THE ISSUE PERSISTED. EVERYTHING WAS THEN DISCONNECTED EXCEPT FOR THE POWER AND THE AMPLIFIER WAS REBOOTED, WHICH SUCCESSFULLY GOT THE AMPLIFIER BACK TO A FLASHING GREEN. ALL THE CABLES WERE THEN RECONNECTED AND THE AMPLIFIER BOOTED TO A SOLID GREEN. THE CASE WAS RESTARTED, BUT THE ERROR MESSAGE "UNABLE TO INITIATE MAGNETICS" WAS STILL DISPLAYED. THE AMPLIFIER WAS POWER CYCLED AND THE PRS'S CAME BACK ONLINE, BUT THE AMPLIFIER BEGAN FLASHING ORANGE AGAIN. IN ORDER TO BEGIN THE CASE, THE AMPLIFIER WAS REPLACED, BUT THE ISSUE WAS NOT RESOLVED. AFTER ADDITIONAL TROUBLESHOOTING, IT WAS DETERMINED THAT THE ENSITE X FIELD FRAME WAS THE CAUSE OF THE ISSUE. ABOUT AN HOUR WAS SPENT TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842136 ↗
• MalfunctionApr 8, 2026Application Program Freezes or Fails to Launch

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A PROCEDURAL DELAY. IN VOXEL MODE, ON ENSITE X 3.1.1 SOFTWARE, IT WAS NOTED THAT THE SYSTEM SUDDENLY BECAME CHOPPY AND ABNORMAL WHEN THE STUDY WAS ENTERED AND ANY OPERATION WAS ATTEMPTED TO BE PERFORMED. THE SURFACE AND INTRACARDIAC ELECTROGRAMS DISPLAYED AS A MAGENTA-COLORED BASELINE, AND THE SYSTEM FROZE. THE CONNECTIONS WERE CHECKED AND CONFIRMED TO BE CORRECT. A FORCED LOGOUT OF THE SYSTEM WAS PERFORMED USING CTRL + ALT + DELETE AND THE SYSTEM WAS REBOOTED, BUT THE ISSUE PERSISTED EVEN AFTER FIVE TO TEN REBOOTS. WHEN SHUTTING DOWN THE SYSTEM, AN ERROR STATING "HARDWARE ERROR" DISPLAYED JUST BEFORE THE SYSTEM POWERED OFF. THE ISSUE INTERFERED WITH LOADING PRESETS, ADDING CATHETERS, AND PERFORMING SET METAL AND INITIATING MAPPING. WHEN THE ADVISOR HD GRID X AND TACTIFLEX CATHETERS WERE AUTOMATICALLY RECOGNIZED, THE SYSTEM WAS ABLE TO MAINTAIN STABLE PERFORMANCE, AND MINIMAL NAVIGATION WAS POSSIBLE IN NAVX MODE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY PERFORMING ONLY PVI IN NAVX MODE UNDER FLUOROSCOPIC AND ICE GUIDANCE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817227 ↗
• MalfunctionMar 31, 2026Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE. THERE WAS A PROCEDURAL DELAY. THE POTENTIALS OF ELECTRODES 1-2 DID NOT APPEAR AFTER INSERTION INTO THE PATIENT AND THEY WOULD NOT DISPLAY AS EXPECTED EITHER. ELECTRODES 3-4 WERE NORMAL. THE CABLE AND CATHETER WERE REPLACED WITH NO RESOLUTION. THE PROCEDURE WAS SWITCHED TO NON-ABBOTT MANUFACTURER (JOHNSON & JOHNSON) TO COMPLETE THE PROCEDURE. LATER ON, IT WAS DETERMINED THAT THE ENSITE X AMPERE CONNECT CABLE WAS THE CAUSE OF THE ISSUE RESOLVED AFTER REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745349 ↗
• MalfunctionMar 31, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  DURING THE RADIOFREQUENCY ABLATION SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A PROCEDURAL DELAY. IT WAS NOTED THAT THE ENSITE X SYSTEM WAS "FREEZING". IT WAS NOTED THAT THE MOUSE WAS ABLE TO MOVE, BUT WAS UNABLE TO CLICK ANY MENUS, WINDOWS, OR FUNCTIONS. TROUBLESHOOTING INCLUDED REBOOTING THE ENSITE X SYSTEM AND REPLACING THE ENSITE X DWS, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744659 ↗
• MalfunctionMar 30, 2026Component Missing; Installation-Related Problem

  THIS REPORT INCLUDES UPDATED DEVICE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716295 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem

  DURING AN ABLATION PROCEDURE, COMMUNICATION ISSUES WITH THE AMPLIFIER RESULTED IN A PROCEDURAL DELAY. THERE WAS A COMMUNICATION ISSUE WHICH RESULTED IN THE CATHETERS APPEARING DISTORTED AND STRETCHED FLAT. TROUBLESHOOTING INCLUDED EXCHANGING THE SURFACELINK, THE PATCHES, REFERENCE PATCH, CATHETERS, STARTING A NEW STUDY, RESTARTING THE DISPLAY WORKSTATION AND AMPLIFIER, CHANGING OUTLETS AND CABLES, AND ENSURING THAT PATIENT DATA CRITERIA WAS ENTERED CORRECTLY. THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED BY EXCHANGING THE AMPLIFIER. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708977 ↗
• MalfunctionMar 26, 2026Communication or Transmission Problem

  DURING PVC (PF) PROCEDURE, COMMUNICATION ISSUES WITH THE AMPLIFIER RESULTED IN A PROCEDURAL DELAY. THE PROCEDURE WAS STARTED IN ENSITE X VOXEL MODE, AND THE ADVISOR HD GRID X CATHETER WAS RECOGNIZED, AND THE ELECTRIC POTENTIALS WERE DISPLAYED, BUT THE CATHETER WAS NOT DISPLAYED. WHEN SWITCHING TO NAVX MODE, IT WAS DISPLAYED, SO A MAGNETIC SENSOR ISSUE WAS SUSPECTED. THE CABLE WAS REPLACED, THE CATHETER WAS REPLACED, AND THE ENSITE X WAS RESTARTED WITH NO RESOLUTION. SINCE IT WAS CONNECTED TO PORT 8 ON THE ENSITE X AMPLIFIER, THE PORT WAS CHANGED TO PORT 7, AND THE CATHETER WAS DISPLAYED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE ENSITE X AMPLIFIER AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700202 ↗

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