EnSite™ ENSITE-FF-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067032195), received between Mar 14, 2022 and Sep 28, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• 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 ↗
• 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 ↗
• InjuryMar 19, 2026Mechanical Problem

  IT WAS REPORTED THAT WHILE PREPARING THE CATH LAB FOR AN EP PROCEDURE THAT A WORKPLACE INJURY WAS SUSTAINED. WHILE SETTING UP THE ENSITE X SYSTEM, IT WAS NOTED THAT THE PRS-P AND PRS-A WERE NOT IN PROPER POSITION. WHILE ADJUSTING THE FIELD FRAME AND MOUNTING BRACKET, A PULL WAS FELT ALONG THE UPPER AND LOWER BACK. THE PAIN WORSENED THROUGHOUT THE PROCEDURE AND RESULTED IN AN URGENT CARE VISIT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24641046 ↗
• MalfunctionDec 8, 2025Electromagnetic Interference; Electromagnetic Interference

  DURING AN PFA PROCEDURE, ELECTRICAL INTERFERENCE ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOT POSSIBLE TO CHECK OR SET THE METAL BASELINE. TROUBLESHOOTING INCLUDED ADJUSTING THE PRS PATCHES AND MAGNET, AND REBOOTING THE DWS, BUT ISSUE PERSISTED. REPLACING THE ENSITE X FIELD FRAME 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 23746990 ↗
• MalfunctionNov 10, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING PREPARATION FOR AN ATRIAL FIBRILLATION PROCEDURE, THE FIELD FRAME WAS PLUGGED IN INCORRECTLY, AND AFTER THIS THE CABLE AND PLUG OF THE FIELD FRAME WAS BURNED. THE FIELD FRAME AND FIELD FRAME CABLE WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513590 ↗
• MalfunctionNov 17, 2024Material Twisted/Bent; Material Twisted/Bent

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, DURING SET UP WITH THE PATIENT ON THE TABLE, IT WAS NOTED THAT PINS ON THE FIELD FRAME PORT WERE BENT RESULTING IN CANCELLATION OF THE PROCEDURE. AFTER THE MAGNETIC SENSORS WERE PUT IN PLACE AND IT WAS ATTEMPTED TO CONNECT THE FIELD FRAME GENERATOR THE ISSUE WAS FOUND. ATTEMPTS TO RECORRECT THE PINS WERE UNSUCCESSFUL, AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703130 ↗
• MalfunctionJun 6, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS NO CONNECTION TO THE FIELD FRAME GENERATOR WHICH RESULTED IN A DELAY. THE PROCEDURE WAS DELAYED APPROXIMATELY 45 MINUTES WHILE ANOTHER FIELD FRAME GENERATOR AND FIELD FRAME CONNECTOR CABLE WERE ACQUIRED FROM A SECONDARY SYSTEM WITHIN THE FACILITY. FURTHER TROUBLESHOOTING REVEALED THAT THE FIELD FRAME GENERATOR AND FIELD FRAME CONNECTOR CABLE IN QUESTION DID NOT COMMUNICATE WITH THE ENSITE X SYSTEM. THE SECONDARY FIELD FRAME GENERATOR AND FIELD FRAME CONNECTOR CABLE CONNECTED APPROPRIATELY AND WERE USED TO COMPLETE THE CASE SUCCESSFULLY WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072564 ↗
• MalfunctionMay 5, 2023Electromagnetic Interference; Electromagnetic Interference

  DURING AN ATYPICAL ATRIAL FLUTTER ABLATION PROCEDURE, AN ERROR MESSAGE WAS NOTED STATING: "MAGNETIC GENERATOR NOT CONNECTED" AND THE PROCEDURE WAS CANCELLED. CONNECTIONS WERE CHECKED AND IT WAS NOTED THAT THE CABLE CONNECTION TO THE FIELDFRAME WAS NOT CONNECTED PROPERLY. THE PINS IN THE CABLE WERE BENT AND TOUCHING ONE ANOTHER. THE CABLE WAS DISCONNECTED FROM THE AMPLIFIER, AND THE PINS WERE BENT BACK INTO THE NORMAL POSITION. THE SYSTEM WAS REBOOTED MULTIPLE TIMES, BUT THE ISSUE PERSISTED. THE FIELD FRAME AND CABLE WERE THEN EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. AS A POSSIBLE RIGHT SIDED TACHYCARDIA WAS SEEN ON THE INSERTED CATHETERS, IT WAS DECIDED TO MAP THE RIGHT ATRIUM IN NAVX MODE WITHOUT SENSOR FUNCTION. A POSSIBLE SUBSTRATE WAS SEEN, TOGETHER WITH AN ACTIVATION MAP THAT COULD INDICATE RIGHT SIDED ATYPICAL FLUTTER. ABLATION WAS PERFORMED USING TACTICATH SE CATHETER AND PLUGGED IN AS A DIAGNOSTIC CATHETER ON THE 20 PIN PINBOARD, SINCE IT WAS NOT SHOWN ON ENSITE DUE TO AN ISSUE WITH MAGNETICS. ABLATION WAS PERFORMED BUT THE TACHYCARDIA PERSISTED. ENTRAINMENT PACING WAS PERFORMED, INDICATING LEFT SIDED TACHYCARDIA. IT WAS DECIDED NOT TO INSERT CATHETERS INTO THE LEFT ATRIU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876386 ↗
• MalfunctionFeb 14, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE, A COMMUNICATION ISSUE OCCURRED AND THE CASE WAS CANCELLED. DURING THE PROCEDURE, THE PRS'S WERE NOT DISPLAYING EVEN THOUGH THEY WERE WITHIN THE FIELD FRAME. THE SYSTEM WAS REBOOTED, A NEW STUDY WAS STARTED, THE PATCHES WERE REPLACED, THE PRS-A AND PRS-P WERE SWAPPED OUT. THE FIELD FRAME CABLE WAS UNPLUGGED, AND THE ENDS WERE SWAPPED. THERE WERE NO BENT PINS OBSERVED. THE MAGNETS ISSUE WAS NOT RESOLVED. THE VOXEL STUDY WAS CLOSED AND THE PROCEDURE CONTINUED IN NAVX MODE WITH NO MAGNETS. THE PATIENT DEVELOPED MULTIPLE VTS SO THE PHYSICIAN DIDN¿T FEEL COMFORTABLE CONTINUING THE PROCEDURE IN NAVX SINCE THE PROCEDURE HAD BEEN SCHEDULED SPECIFICALLY TO BE DONE IN VOXEL MODE. THEREFORE, THE PROCEDURE WAS ABORTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372271 ↗
• MalfunctionMar 14, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN EPICARDIAL VENTRICULAR TACHYCARDIA (VT) PROCEDURE, THE MAGNETIC FIELD FRAME WAS NOT RECOGNIZED BY THE SYSTEM IN NAVX OR VOXEL MODE AND A DELAY OCCURRED. THE PRS A AND PRS P WERE EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. THE SYSTEM WAS RESTARTED 4 TIMES WITHOUT SUCCESS. DISCONNECTING THE CABLES FROM THE AMPLIFIER AND RESTARTING DID NOT RESOLVE THE ISSUE. DISCONNECTING AND RE-CONNECTING THE FRAME CABLE DID NOT RESOLVE THE ISSUE. THE PROCEDURE CONTINUED WITHOUT MAGNETICS AND WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759919 ↗