EnSite™ ENSITE-SRFLNK-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067033611), received between Nov 8, 2021 and Mar 18, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (5 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.

• MalfunctionMar 18, 2026Signal Artifact/Noise

  DURING THE PROCEDURE, THE PROCEDURE WAS CANCELED DUE TO NOISE ISSUES. WHEN STARTING THE PROCEDURE, THE SURFACE LEADS ON THE NON-ABBOTT RECORDING SYSTEM (GE) WERE NOISY. THE ECG OUTPUT BOX WAS CHANGED WITH NO RESOLUTION. THE SIGNALS ON THE ENSITE SYSTEM WERE FINE. THE PROCEDURE WAS CANCELLED. LATER ON, THE ISSUE WAS ABLE TO BE REPLICATED WITH THE SURFACELINK, AND ONCE THE SURFACELINK WAS EXCHANGED THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630521 ↗
• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A DELAY DUE TO THE ENSITE X SURFACELINK MODULE MISSING A PIN. THE PATCHES WERE NOT ABLE TO BE CONNECTED. THE PATCHES WERE REPLACED, THE ENSITE X AMPLIFIER WAS REBOOTED, AND THE ENSITE X DWS WAS REBOOTED, BUT THE ISSUE PERSISTED. THE ENSITE X SURFACELINK WAS REPLACED, AND THE ISSUE WAS RESOLVED. UPON INSPECTION, IT WAS NOTED THAT THE ENSITE X SURFACELINK WAS MISSING A PIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650619 ↗
• MalfunctionSep 9, 2025Signal Artifact/Noise; Signal Artifact/Noise

  AT THE BEGINNING OF AN ATRIAL FLUTTER PROCEDURE, SIGNAL ISSUED OCCURRED WHICH CAUSED PROCEDURE DELAY. NO SIGNALS WERE SEEN WHEN CONNECTED TO THE ENSITE X 20-PIN CIM. IT WAS NOTED THAT THE SIGNALS WERE DISPLAYED FOR A SHORT TIME, BUT THEN DISAPPEARED. TROUBLESHOOTING INCLUDED CONNECTING THE CIM TO PORT 7, 8, AND 4, BUT ISSUE PERSISTED. THE NON-ABBOTT (GE) RECORDING SYSTEM HAD MANAGED TO GET SIGNALS WITHOUT ANY ISSUES AND THE CATHETER WAS ABLE TO BE VISUALIZED ON THE ENSITE X SYSTEM. CHANGING THE PIN FROM 1 TO 11 MADE THE SIGNALS NOISY. TECH SUPPORT HAD ADVISED TO SWITCH TO THE 80-PIN CIM, BUT THE SAME ISSUE WAS STILL SEEN. FURTHER TROUBLESHOOTING INCLUDED CHECKING THE RL DRIVE, SHUTTING OFF THE NON-ABBOTT (GE) AMPLIFIER, DOING A FULL REBOOT, AND STARTING A NEW CASE WITH THE EXISTING PATIENT. AFTER VALIDATION WAS ACHIEVED, A SURFACE ELECTRODE IMPEDANCE ERROR WAS DISPLAYED BUT REPLACING THE SYSTEM REFERENCE DID NOT RESOLVE THE ISSUE. ANOTHER ATTEMPT WAS MADE TO REBOOT THE AMPLIFIER AND REVALIDATE BUT THE ERROR CONTINUED TO PERSIST, AND THE ECG SIGNALS WERE STILL LOST. THE CASE WAS PAUSED FOR ABOUT AN HOUR TO GET ANOTHER SURFACE LINK FROM A NEIGHBORING HOSPITAL AND THE PROCEDURE WAS CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006586 ↗
• MalfunctionApr 2, 2025Impedance Problem; Impedance Problem

  DURING THE PROCEDURE, A SURFACE IMPEDANCE ERROR DISPLAYED SHORTLY AFTER VALIDATION AND THE PROCEDURE WAS CANCELLED. ADDITIONALLY, THERE WERE PURPLE SIGNALS ON THE ENSITE X SYSTEM. THE ENSITE X SURFACELINK WAS REPLACED, AND THE ISSUE WAS RESOLVED. PER ABBOTT PERSONNEL, THE AF PORTION OF THE PROCEDURE WAS CANCELLED DUE TO THE SURFACE LINK ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752895 ↗
• MalfunctionAug 14, 2024Output Problem; Output Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SURFACELINK HAD AN OUTPUT ISSUE WHICH RESULTED IN A CANCELLATION OF THE PROCEDURE. WHILE THE PATIENT WAS PREPPED, THERE WAS AN AMPLIFIER ERROR ON ENSITE X SYSTEM DISPLAYING "SURFACE ELECTRODE IMPEDANCE ERROR. CONFIRM ORIGINAL SURFACE ELECTRODE PLACEMENT". ATTEMPTS AT TROUBLESHOOTING INCLUDED REBOOTS OF THE AMPLIFIER AND DWS, SURFACE ELECTRODE REPLACEMENT TWICE, AND A 12-LEAD REPLACEMENT. THE PROCEDURE WAS ABORTED DUE TO LACK OF MAPPING AND THE ANATOMY WAS CONSIDERED TOO DIFFICULT TO PURSUE A FLUOROSCOPY AND ICE ONLY PROCEDURE. THE ISSUE WAS RESOLVED BY REPLACING THE SURFACELINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986543 ↗
• MalfunctionJul 18, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, NOISE ISSUES RESULTED IN A PROCEDURAL DELAY. PURPLE SIGNALS WERE OBSERVED ON THE SURFACELINK. THE LEAD SET AND THE AMPLIFIER WERE BOTH REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE SURFACELINK WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778795 ↗
• MalfunctionDec 19, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  AT THE START OF THE ATRIAL FIBRILLATION CASE, IMPEDANCE ERRORS RESULTED IN A PROCEDURAL DELAY. WHEN DISCONNECTING A LEAD FROM THE MODULE, THE ISSUE RESOLVED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. A PATCH IMPEDANCE ERROR WAS NOTED ON THE SYSTEM AND THERE WAS NO ECG (PURPLE LINES). A NEW SYSTEM REFERENCE PATCH WAS TRIED, ECG GEL WAS APPLIED TO THE PATCH, AND THE PATIENT WAS RE-PATCHED, BUT THE ISSUE PERSISTED. WHEN DISCONNECTING THE RIGHT LEG LEAD FROM THE SURFACELINK, THE SIGNALS RETURNED ON ENSITE X. THE PROCEDURE WAS DELAYED, AND THE PHYSICIAN FELT THAT IT WAS CLINICALLY SIGNIFICANT. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358456 ↗
• MalfunctionJun 6, 2023Signal Artifact/Noise; Signal Artifact/Noise

  DURING A WOLFF-PARKINSON-WHITE PROCEDURE, THERE WAS A SIGNAL ISSUE WITH THE ENSITE X EP SYSTEM SURFACELINK MODULE WHICH RESULTED IN A DELAY OF PROCEDURE BY 1.5 HOURS. THE DELTA WAS MAPPED AND SUCCESSFULLY ELIMINATED BY RF ABLATION. LATER, POST ABLATION, THE CATHETER WAS FOUND TO BE TOO THIN. THE SETUP WAS 7FR BUT IT LOOKED LIKE A 4FR. THE SIGNAL FOR THE RESPIRATORY METER WAS ALSO ABNORMAL. THEN, THE INTRACARDIAC ECG WAS OBSERVED WITH ARTIFACTS BEFORE ALL SIGNALS WERE GONE. THE SURFACE ECG SIGNALS WERE ALSO NOT APPEARING. THE CONNECTION OF THE RL WAS CHECKED AND SECURED BUT THERE WAS NO IMPROVEMENT. HOWEVER, IT WAS FOUND THAT THERE WAS ANOTHER ACCESSORY PATHWAY WHICH NEEDED MAPPING. A NEW SURFACE LINK MODULE WAS REQUESTED FOR URGENT DELIVERY. WHILE WAITING FOR THE NEW SURFACE LINK MODULE, THE CASE WAS CONTINUED USING CRYO INSTEAD OF 3D MAPPING FOR THE SEPTAL PATHWAY ABLATION. AFTER THE SURFACE LINK MODULE ARRIVAL, MAPPING COULD BE DONE AND IT WAS FOUND THAT THE CRYO WAS NOT NECESSARY. THE CASE WAS THEN COMPLETED SUCCESSFULLY WITH THE NEW SURFACE LINK AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071950 ↗
• MalfunctionJun 22, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A VALIDATION ISSUE OCCURRED RESULTING IN A DELAY OF THE PROCEDURE. THE SYSTEM WAS CHANGED TO A NON-ABBOTT MAPPING SYSTEM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777442 ↗
• MalfunctionNov 8, 2021Communication or Transmission Problem; Impedance Problem; Communication or Transmission Problem; Impedance Problem

  RELATED MANUFACTURER REF: 2184149-2021-00339, 3008452825-2021-00509. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A PROLONGED PROCEDURE OCCURRED DUE TO A "SURFACE ELECTRODE IMPEDANCE ERROR" MESSAGE DISPLAYING WHILE PUNCTURING THE INGUINAL REGION IN VOXEL MODE, THE BODY SURFACE ECG 12 NO LONGER DISPLAYING, AND THE TROUBLESHOOTING INVOLVED IN ORDER TO RESOLVE THE ISSUE. ULTIMATELY THE SYSTEM AND THE PATCHES WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770262 ↗