Advisor™ D-AVSE-D10-F20Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067024817), received between Jul 3, 2018 and Jun 13, 2025 — classified as 1 death, 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT INCLUDES AN UPDATED EVENT DESCRIPTION AND UPDATED HEALTH CLINICAL CODE AND HEALTH IMPACT CODE. DURING AN ATRIAL FIBRILLATION PROCEDURE, WHILE MAPPING, AV BLOCK OCCURRED WHICH WAS TREATED WITH STIMULATION TO STABILIZE THE PATIENT. THE PATIENT WAS SEDATED WITH DEXDOR AND MAPPING WAS PERFORMED USING BOTH THE TACTICATH SE CATHETER AND THE ADVISOR FL SE CATHETER. TOWARDS THE END OF THE MAPPING THE PATIENT WENT INTO COMPLETE AV BLOCK WITH ST SEGMENT ELEVATION IN THE ABSENCE OF HEMODYNAMIC LESIONS ON CORONARY IMAGING. STIMULATION WAS ADMINISTERED IN THE CORONARY SINUS WITH THE CATHETER AND AFTER A FEW SECONDS SINUS RHYTHM WAS RESTORED. A CARDIOGRAM WAS DONE WHICH WAS NEGATIVE. THE PATIENT WAS UNABLE TO BE AWAKENED AND DEVELOPED A COMA, SO CT AND MRI EXAMS WERE DONE WHICH WERE NEGATIVE. THE PATIENT WAS ADMITTED TO ICU AND GRADUALLY RECOVERED CONSCIOUSNESS THE NEXT DAY. CT SCANS WERE REPEATED, AND AN ISCHEMIC ENCEPHALIC LESION APPEARED WITH CONCURRENT MOTOR DEFICIT OF THE UPPER LIMB. THE PHYSICIANS DO NOT THINK THAT ANY ABBOTT PRODUCTS ARE INVOLVED IN THE REPORTED EVENT. NO ABLATIONS HAD BEEN PERFORMED PRIOR TO THE REPORTED AV BLOCK. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABB

  Patient problems: Heart Block; Stroke/CVA

  MAUDE report 22202557 ↗
• MalfunctionApr 18, 2023Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REF: 3008452825-2023-00167. DURING AN ATRIAL TACHYCARDIA PROCEDURE, A COMMUNICATION ISSUE OCCURRED WITH THE ADVISOR HD GRID CATHETER RESULTING IN A DELAY TO THE PROCEDURE. THE ADVISOR HD GRID CATHETER WAS INSERTED INTO THE RIGHT ATRIUM AND MAPPING WAS PERFORMED. THEN THE ADVISOR FL CATHETER WAS INSERTED INTO THE LEFT ATRIUM AND THE MAPPING CATHETER OF THE ENSITE X SETTING WAS SET TO THE ADVISOR FL. THE REFERENCE (CS) COULD NOT BE COLLECTED, THE MAPPING COULD NOT BE PERFORMED WITH THE ADVISOR FL CATHETER WHILE THE ELECTRIC POTENTIALS WAS NOT DISPLAYED. THE ELECTRIC POTENTIALS OF THE ADVISOR FL CATHETER WERE DISPLAYED ON THE RECORDING SYSTEM. THE CATHETER AND THE CABLE WERE RE-CONNECTED, AND RE-SET TO THE CATHETER SET UP SCREEN OF THE ENSITE X, THE DWS WAS RE-STARTED, AND THE ADVISOR FL CATHETER WAS REPLACED WITH A SECOND ONE, BUT WITH NO RESOLUTION. THE LEFT ATRIUM WAS MAPPED WITH THE ADVISOR HD GRID CATHETER. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED ONLY SECOND CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766377 ↗
• MalfunctionApr 18, 2023Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REF: 3008452825-2023-00168. DURING A ATRIAL TACHYCARDIA PROCEDURE, A COMMUNICATION ISSUE OCCURRED WITH THE ADVISOR HD GRID CATHETER RESULTING IN A DELAY TO THE PROCEDURE. THE ADVISOR HD GRID CATHETER WAS INSERTED INTO THE RIGHT ATRIUM AND MAPPING WAS PERFORMED. THEN THE ADVISOR FL CATHETER WAS INSERTED INTO THE LEFT ATRIUM AND THE MAPPING CATHETER OF THE ENSITE X SETTING WAS SET TO THE ADVISOR FL. THE REFERENCE (CS) COULD NOT BE COLLECTED, THE MAPPING COULD NOT BE PERFORMED WITH THE ADVISOR FL CATHETER WHILE THE ELECTRIC POTENTIALS WAS NOT DISPLAYED. THE ELECTRIC POTENTIALS OF THE ADVISOR FL CATHETER WERE DISPLAYED ON THE RECORDING SYSTEM. THE CATHETER AND THE CABLE WERE RE-CONNECTED, AND RE-SET TO THE CATHETER SET UP SCREEN OF THE ENSITE X, THE DWS WAS RE-STARTED, AND THE ADVISOR FL CATHETER WAS REPLACED WITH A SECOND ONE, BUT WITH NO RESOLUTION. THE LEFT ATRIUM WAS MAPPED WITH THE ADVISOR HD GRID CATHETER. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED ONLY SECOND CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766374 ↗
• MalfunctionApr 7, 2022Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT NOTED DURING ANALYSIS WHICH REVEALED A TEAR IN THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046118 ↗
• MalfunctionJan 12, 2022Use of Device Problem; Expiration Date Error; Use of Device Problem; Expiration Date Error

  THIS EVENT IS BEING REPORTED AS THE DEVICE USED DURING THE PROCEDURE HAD EXPIRED. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236897 ↗
• DeathMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 8465820 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2019-00078, 3008452825-2019-00067, 3005334138-2019-00079, 3005334138-2019-00080. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. JUST AFTER TRANSSEPTAL ACCESS WAS OBTAINED AND DURING LEFT ATRIAL GEOMETRY RECONSTRUCTION, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8345542 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00030. DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. WHILE ABLATING IN THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8288432 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2018-00080, 3005334138-2018-00432, 3008452825-2018-00390. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. AT THE END OF THE PROCEDURE, AFTER REMOVING ALL DEVICES, THE PATIENT BECAME HYPOTENSIVE. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED, REVEALING A PERICARDIAL EFFUSION MEASURING 2 CENTIMETERS. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8074884 ↗
• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 9680001-2018-00100, 3008452825-2018-00220, 3005334138-2018-00187, 3005334138-2018-00188, 3008452825-2018-00221. FOLLOWING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AS THE DEVICES WERE REMOVED THE PATIENT BECAME HYPOTENSIVE. PHARMACOLOGICAL INTERVENTION WAS GIVEN BUT THE PATIENT¿S BLOOD PRESSURE REMAINED LOW. AN ECHOCARDIOGRAM WAS PERFORMED, REVEALING A GLOBAL EFFUSION CAUSING CARDIAC TAMPONADE. A DRAIN WAS INSERTED HOWEVER THE PERICARDIUM KEPT REFILLING SO OPEN-HEART SURGERY WAS PERFORMED. A PERFORATION WAS LOCATED AT THE BASE OF THE LEFT ATRIAL APPENDAGE WHICH REQUIRED A SUTURE TO CLOSE. THE PATIENT STABILIZED AND IS RECOVERING FROM THE SURGERY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 7658106 ↗