EnSite™ ENSITE-SEK-5-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067032379), received between Mar 28, 2022 and Apr 23, 2026 — classified as 3 injuries, 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 9, 2025Communication or Transmission Problem; Impedance Problem; Communication or Transmission Problem; Impedance Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE WITH PULSED FIELD ABLATION, THERE WAS A DELAY DUE TO A PATCH CONNECTION AND IMPEDANCE ISSUES RESULTING IN THE ENSITE SYSTEM BEING RESTARTED FOUR TIMES. AFTER STARTING AN ENSITE X STUDY IN NAVX MODE, IT WAS NOTED THAT AN ERROR OF "LEFT LEG OR REF ELECTRODE PATCH DISCONNECTED" WOULD INTERMITTENTLY OCCUR, AS WELL AS AN INTERMITTENT "AMPERE DISCONNECTED" ERROR. A "SURFACE ELECTRODE IMPEDANCE" ERROR WOULD ALSO OCCUR, AFTER SUCCESSFULLY VALIDATING THE PATCHES. INTRA-CARDIAC SIGNALS COULD BE SEEN ON THE ENSITE X SYSTEM, BUT NO CATHETER VISUALIZATION. RESPIRATORY COMPENSATION COULD ALSO NOT BE DONE. ADDITIONAL ULTRASOUND GEL WAS APPLIED FIRST TO THE LEG PATCH, THEN THE SYSTEM REFERENCE PATCH, WITH NO RESOLUTION. A SECOND PATCH KIT WAS OPENED, AND THE LEFT LEG PATCH, AND THE SYSTEM REFERENCE PATCH WERE PLACED IN DIFFERENT LOCATIONS ON THE PATIENT BUT STILL DID NOT RESOLVE THE ISSUE. A SECONDARY NAVLINK WAS ALSO TRIED, TO NO SUCCESS. THE ENSITE X SYSTEM WAS REBOOTED FOUR TIMES, WITH NO RESOLUTION. THE PROCEDURE WAS COMPLETED USING CONVENTIONAL NON-MAPPING METHODS, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763861 ↗
• MalfunctionMay 6, 2024Connection Problem; Connection Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A CONNECTION ISSUE OCCURRED WHICH CAUSED A DELAY IN PROCEDURE. AN ERROR MESSAGE WAS NOTED STATING: SURFACE ELECTRODE IMPEDANCE ERROR. CONFIRM ORIGINAL SURFACE ELECTRODE PLACEMENT. REVALIDATION IS RECOMMENDED IF THE PARCH HAS MOVED TO A NEW LOCATION". THE SURFACE LINK WAS EXCHANGED AND THE PATCHES WERE REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE AMPLIFIER WAS THEN REPLACED AND THE ISSUE REMAINED. THE SYSTEM WAS THEN SHUT DOWN COMPLETELY AND THE AMPLIFIER AND COMPUTER REBOOTED. A NEW STUDY WAS STARTED AND THE ISSUE REMAINED. A FEW OF THE CIRCLE IMPEDANCE PATCHES HAD FALLEN OFF THE PATIENT WHEN WE WENT BACK TO LOOK. THOSE WERE REATTACHED AND THE PROCEDURE WAS EVENTUALLY ABLE TO BE COMPLETED BY PRESSING DOWN ON THE DIFFERENT PATCHES AT DIFFERENT POINTS AND SIGNALS WERE REGAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250984 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PATCHES WERE VERY STICKY AND THE PATIENT'S SKIN MINORLY TEARED UNDER THE LEFT ARMPIT UPON REMOVAL. THE AREA HAD BEEN PREPPED FOR PATCH PLACEMENT INCLUDING SHAVING HAIRY AREAS. NO TREATMENT WAS NECESSARY FOR THE SKIN TEAR AND THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH THE PATCHES.

  Patient problems: Skin Tears

  MAUDE report 18057718 ↗
• MalfunctionFeb 28, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN SVT PROCEDURE USING THE ENSITE X SYSTEM IN NAVX MODE, COMMUNICATION ISSUES WERE NOTED WHICH CAUSED DELAYS TO TREATMENT. IT WAS NOTED THAT THERE WERE NO EKG SIGNALS DISPLAYED, ONLY A PINK LINE, ON THE ENSITE COMPUTER BUT THE RECORDING SYSTEM DID HAVE EKG SIGNALS. THERE WERE NO ERROR MESSAGES DISPLAYED ON THE SYSTEM AND THE PATCHES WERE ABLE TO BE VALIDATED SUCCESSFULLY. THE EKG AND PATCH CONNECTIONS TO THE SURFACE LINK AND THE AMPLIFIER WERE CHECKED. IT WAS THE NOTED THAT THE SIGNALS WOULD APPEAR WHEN THE RIGHT LEG PATCH WAS DISCONNECTED BUT THEY WOULD DISAPPEAR WHEN CONNECTED AGAIN. THE RIGHT LEG PATCH WAS REPLACED, THE SYSTEM WAS REBOOTED AND A NEW STUDY WAS STARTED WITH NO RESOLUTION. THE EKG CABLE WAS REPLACED WITH NO RESOLUTION. THE SURFACE LINK WAS REPLACED WITH NO RESOLUTION. A NEW REFERENCE PATCH WAS PUT ON THE PATIENT AND THE EKG SIGNALS SHOWED UP IMMEDIATELY AND THE ISSUE WAS RESOLVED. REVALIDATION WAS DONE BUT THE SYSTEM WOULD NOT ALLOW THAT DUE TO A LEFT LEG PATCH ISSUE SO THE LEFT LEG PATCH WAS REPLACED AS WELL. THE SYSTEM WAS REBOOTED AND A NEW STUDY WAS STARTED. THIS WAS SUCCESSFUL AND THE PROCEDURE WAS STARTED APPROPRIATELY. LATER IN THE PROCEDURE, SOME ERR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454514 ↗
• InjuryOct 1, 2022Failure to Disconnect; Failure to Disconnect

  FOLLOWING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A SKIN TEAR OCCURRED. WHEN THE PATCHES WERE BEING REMOVED AFTER THE PROCEDURE, GROIN PRESSURE WAS HELD WITH ONE HAND, AND THE OTHER HAND REACHED UNDER THE PATIENT¿S BLANKET AND RIPPED OFF THE GROUND PAD. THE SKIN TORE AND WAS BRUISED IN THE AREA WHERE THE GROUND PAD WAS LOCATED. THE PATIENT WAS BANDAGED AND IMMEDIATELY TAKEN CARE OF.

  Patient problems: Skin Tears

  MAUDE report 15524176 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERSISTENT REDO ATRIAL FIBRILLATION PULMONARY VEIN ISOLATION PROCEDURE, THE PATIENTS SKIN WAS DAMAGED WHILE REMOVING THE INNER LEFT LEG PATCH. THE WOUND WAS TREATED WITH GEL AND XEROFORM GAUZE. THE PATIENT WAS REPORTED TO HAVE THIN SKIN. THERE WERE NO PERFORMANCE ISSUES NOTED WITH THE PATCHES.

  Patient problems: Skin Tears

  MAUDE report 13932551 ↗