EnSite™ ENSITE-AMP-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067032157), received between Apr 7, 2021 and Nov 21, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING A PFA PROCEDURE, THERE WAS A SELF-TEST ISSUE WITH THE AMPLIFIER AND SOFTWARE ISSUES RESULTING IN A DELAY. AFTER SETTING UP FOR THE CASE, THE MODE WAS CHANGED FROM VOXEL TO NAVX TO VISUALIZE THE CS AND HIS CATHETERS THAT WERE POSITIONED IN THE HEART UNDER FLUOROSCOPY. THE CATHETERS FROZE AT THE BASE OF THE SCREEN BUT THERE WERE CS AND HIS EGM SIGNALS ON BOTH ENSITE X AND THE NON-ABBOTT (PRUCKA) RECORDING SYSTEM. ADDITIONALLY, WHEN RESPIRATION COMPENSATION WAS PERFORMED, THE FOLLOWING ERROR DISPLAYED, ¿RESPIRATION DATA COLLECTION FAILED. MAY BE CAUSED BY A DAMAGED FIBER CABLE, COMPLEX MODELS, OR RAPID SUCCESSIVE RECORDINGS. RECOLLECT RESPIRATION DATA BEFORE PROCEEDING." THE AMPLIFIER WAS RESTARTED, WHICH RESULTED IN A FLASHING ORANGE LIGHT. THE AMPLIFIER WAS TURNED OFF AGAIN AND THE CASE WAS CLOSED. THE CASE WAS REOPENED AND THE AMPLIFIER TURNED BACK ON, BUT THE FLASHING ORANGE LIGHT REMAINED. EVERYTHING WAS SHUT OFF AND ALL CONNECTIONS TO THE FRONT PANEL OF THE AMPLIFIER WERE RECONNECTED. THE AMPLIFIER WAS THEN TURNED ON AND THE LIGHT WAS GREEN. REVALIDATION WAS PERFORMED, METAL CHECKS WERE DONE AND THE PRS'S WERE GREEN. THE CATHETERS WERE POSITIONED IN THE HEART. THE ADVISOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618374 ↗
• MalfunctionNov 4, 2021Communication or Transmission Problem; Communication or Transmission Problem

  MANUFACTURER REPORT NUMBER: 2184149-2021-00333. DURING THE REDO ATRIAL FIBRILLATION PROCEDURE IN VOXEL MODE, A NEW STUDY WAS STARTED IN THE ENSITE X SYSTEM. THE CPU WAS NOT ABLE TO STABLISH CONNECTION WITH THE AMPLIFIER. THERE WAS AN ERROR MESSAGE REPORTING THE CONNECTION WAS FAILING AND A RESTART WAS RECOMMENDED. THE CPU AND AMPLIFIER WERE REBOOTED FOUR TIMES EACH IN DIFFERENT ORDERS, BUT THE ISSUE PERSISTED. ALL CONNECTIONS IN THE FRONT AND BACK OF THE AMPLIFIER WERE REMOVED AND REATTACHED, AND THE AMPLIFIER WAS RESTARTED AGAIN, BUT THE ISSUE PERSISTED. THE FIBER OPTIC CABLE BETWEEN THE CPU AND THE AMPLIFIER WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED USING THE ENSITE PRECISION SYSTEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, HOWEVER, A PROCEDURE DELAY OCCURRED DUE TO THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752294 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2021-00197, 3008452825-2021-00170, 3008452825-2021-00171, 3008452825-2021-00172, 3005334138-2021-00198. SEVERAL HOURS FOLLOWING A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. FOLLOWING THE PROCEDURE, WHILE USING THE ENSITE X IN VOXEL MODE A PERICARDIAL EFFUSION WAS DETECTED. DURING THE PROCEDURE, THE PATIENT WAS IN STABLE CONDITION AND THE PVI WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. SEVERAL HOURS AFTER THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE, AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE CAUSE AND LOCATION OF THE EFFUSION REMAINS UNKNOWN. PER THE PHYSICIAN, THE REPORTED OVERSIZED SHELL INVOLVING THE ENSITE X MAY HAVE CONTRIBUTED TO THE EFFUSION. THE PATIENT IS CURRENTLY IN STABLE CONDITION AND HAS BEEN DISCHARGED.

  Patient problems: Cardiac Perforation

  MAUDE report 11632031 ↗