Advisor™ VL, Sensor Enabled™ D-AVSE-D20-V1525Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067027269), received between Mar 29, 2021 and Mar 29, 2021 — classified as 3 injuries.

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.

• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3008452825-2021-00172, 3008452825-2021-00171, 3008452825-2021-00170, 3005334138-2021-00197, 2184149-2021-00099. 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 11585651 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REF: 2184149-2021-00091, 3008452825-2021-00175, 3008452825-2021-00176, 3008452825-2021-00177, 2184149-2021-00100. FOLLOWING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ECHOCARDIOGRAM. THE PERICARDIAL EFFUSION WAS TREATED SUCCESSFULLY AND THE PATIENT WAS STABILIZED, HOWEVER, IT IS UNKNOWN HOW IT WAS TREATED. THE PATIENT'S BLOOD PRESSURE WAS STABLE THROUGHOUT THE ENTIRETY OF THE PROCEDURE AND THERE WERE NO PERFORMANCE ISSUES WITH ANY DISPOSABLE DEVICES. PER THE PHYSICIAN, THE REPORTED OVERSIZED SHELL INVOLVING THE ENSITE X MAY HAVE CONTRIBUTED TO THE EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 11584650 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2021-00185, 34138-2021-00209, 3008452825-2021-00186, 3008452825-2021-00187, 2184149-2021-00101. FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE IN ENSITE X VOXEL MODE, A PERICARDIAL EFFUSION WAS DETECTED POSTERIOR RIGHT VENTRICLE. DURING THE PROCEDURE IT WAS DIFFICULT TO MANEUVER THE SHEATHS TOWARDS THE VENA CAVA. HOWEVER, THE LEFT PULMONARY VEINS WERE SUCCESSFULLY ABLATED. THE DECISION WAS THEN MADE TO STOP THE PROCEDURE DUE TO THE MANEUVERING DIFFICULTIES. THE PATIENT WAS IN CONSCIOUS SEDATION AND HAD A STABLE BLOOD PRESSURE. AT THE END OF THE PROCEDURE, A PERICARDIAL EFFUSION WAS DETECTED WITH NO INTERVENTION REQUIRED. THE BLOOD PRESSURE STABILIZED, THE PATIENT RECOVERED AND WAS DISCHARGED. PER THE PHYSICIAN, THE REPORTED OVERSIZED SHELL INVOLVING THE ENSITE X MAY HAVE CONTRIBUTED TO THE EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 11582308 ↗