Advisor™ VL, Sensor Enabled™ D-AVSE-DF20-V1525Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067027283), received between Jul 9, 2020 and Jun 24, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Entrapment of Device; Fracture; Activation, Positioning or Separation Problem; Entrapment of Device; Fracture; Activation, Positioning or Separation Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE LOOP OF THE CATHETER WAS DAMAGED AND GOT CAUGHT ON HEART TISSUE. WHEN THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM, IT WAS FOUND THAT THE CATHETER MANEUVERING AND COLLECTION OF GEOMETRY WERE DIFFICULT. THE CATHETER WAS REMOVED WITH NO INTERVENTION NEEDED, AND IT WAS NOTED TO BE DAMAGED. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323573 ↗
• InjuryFeb 21, 2025Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE ADVISOR VL CATHETER WAS ADVANCED INTO THE CORDAGE OF THE MITRAL VALVE. AFTER MANIPULATION ATTEMPTS, IT WAS NOT POSSIBLE TO REMOVE THE CATHETER. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL REMOVAL OF THE DEVICE BY CARDIAC MICROSURGERY WITHOUT ANY DAMAGE AND THE PATIENT IS STABLE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 21437925 ↗
• InjuryFeb 6, 2025Entrapment of Device; Entrapment of Device

  DURING A PROCEDURE, THE CATHETER BECAME ENTANGLED IN THE MITRAL VALVE AND COULD NOT BE FREED. THE CATHETER HAD TO BE SURGICALLY REMOVED, AND THE MITRAL VALVE HAD TO BE REPLACED. THE PATIENT IS STABLE.

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 21327534 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED. MAPPING WAS PERFORMED USING THE ENSITE. DURING MAPPING, THE SYSTOLIC BLOOD PRESSURE TEMPORARILY DROPPED INTO THE 40S. AN INTRACARDIAC ECHO CONFIRMED A SMALL AMOUNT OF PERICARDIAL FLUID, BUT DRAINAGE WAS NOT REQUIRED. SEDATION WAS RELEASED, AND A FOLLOW-UP OBSERVATION WAS PERFORMED. AFTER THAT, THE SYSTOLIC BLOOD PRESSURE INCREASED TO THE NORMAL RANGE, BUT THE PROCEDURE WAS DISCONTINUED, AND FOLLOW-UP OBSERVATION WAS PERFORMED. THE CATHETER WAS INSERTED DEEP INTO THE LEFT ATRIAL APPENDAGE DURING MAPPING, AND THERE WAS A POSSIBILITY THAT THE CARDIAC PERFORATION HAPPENED AT THAT TIME. THE PHYSICIAN ALLEGES THAT THE MAPPING CATHETER CAUSED THE CARDIAC PERFORATION. THERE HAVE BEEN NO SIGNIFICANT CHANGES IN THE PATIENT'S CONDITION SINCE THE DAY OF THE EVENT AND THE PATIENT IS STILL HOSPITALIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES IN THIS EVENT.

  Patient problems: Cardiac Perforation

  MAUDE report 19911377 ↗
• MalfunctionJan 9, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  DURING THE PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE USING THE ADVISOR¿ VL, SENSOR ENABLED¿ CIRCULAR MAPPING CATHETER, IT WAS NOTED THAT IT BECAME ENTANGLED WITH THE CHORDAE TENDINEAE. THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM, AND THE CATHETER INSERTED INTO THE LEFT VENTRICLE. WHEN THE GEOMETRY OF THE LEFT ATRIUM WAS BEING CREATED, IT WAS NOTED THE CATHETER WAS ENTANGLED WITH THE CHORDAE TENDINEAE, AND IT COULD NOT COME OUT. THE CATHETER WAS ROTATED, BUT IT WAS STILL HARD TO REMOVE, SO THE SHEATH WAS REMOVED. NO DAMAGE WAS SEEN ON THE CATHETER, BUT IT WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122891 ↗
• InjuryOct 8, 2021Entrapment of Device; Entrapment of Device

  NO ADDITIONAL TREATMENT FOR MYOCARDIAL DAMAGE WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599752 ↗
• InjuryDec 28, 2020Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN MAPPING OF THE LEFT ATRIUM WAS BEING PERFORMED ON THE ENSITE, THE CATHETER ENTERED THE LEFT VENTRICLE AND BECAME ENTANGLED IN THE CHORDAE TENDINEAE AND THE PAPILLARY MUSCLES, AND THE CATHETER COULD NOT BE REMOVED FROM THERE. TORQUE WAS APPLIED TO THE CATHETER BY VIEWING THROUGH THE ECHOCARDIOGRAM, THE CATHETER WAS PULLED INTO THE SHEATH, AND PACING WAS APPLIED WITH THE CATHETER BEING MOVED, BUT THE CATHETER COULD NOT BE REMOVED. THE PATIENT WAS MOVED TO AN OPERATING ROOM IN THE CARDIOVASCULAR SURGERY UNIT AND THE CATHETER WAS REMOVED BY THORACOSCOPY AND A VALVULOPLASTY WAS PERFORMED FOR TORN PAPILLARY MUSCLES. IT WAS FOUND THAT THE CHORDAE TENDINEAE AND THE PAPILLARY MUSCLES WERE TORN OFF AND ENTANGLED. THE CATHETER WAS DISPOSED OF AT THE HOSPITAL.

  Patient problems: Injury

  MAUDE report 11078388 ↗
• InjuryNov 18, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  RELATED MANUFACTURER REPORT NUMBER: 3008452825-2020-00604. AFTER A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE, A BLOOD CLOT WAS NOTED TO BE ATTACHED TO THE ELECTRODE 7. AN ECHOCARDIOGRAM WAS PERFORMED AFTER THE PROCEDURE, AND NO FLOATING SUBSTANCE/MATERIAL LIKE A BLOOD CLOT WAS FOUND IN THE LEFT ATRIUM AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Thrombus

  MAUDE report 10859757 ↗
• InjurySep 14, 2020Difficult to Remove; Difficult to Remove

  DURING RIGHT ATRIAL GEOMETRY, THE CATHETER BECAME LODGED IN THE TRICUSPID VALVE APPARATUS (CHORDAE TENDINEAE). THE CATHETER BECAME GOT CAUGHT IN THE CHORDAE TENDINEAE AND WHEN PULLING THE CATHETER BACK INTO THE SHEATH TO FREE THE CATHETER, THE PAPILLARY MUSCLE WAS RUPTURED. THE RUPTURE CAUSED A PROLAPSE OF THE TRICUSPID VALVE (TV) AND REGURGITATION. THE PATIENT WAS STABLE UNDER GENERAL ANESTHESIA, SO THE PROCEDURE CONTINUED. PULMONARY VEIN ISOLATION AND A CTI LINE WAS COMPLETED USING THE SAME ADVISOR VL AS THE DIAGNOSTIC CATHETER. THE PHYSICIAN BELIEVES THE TRICUSPID VALVE REGURGITATION WAS A RESULT OF THE CATHETER GETTING STUCK IN THE CHORDAE AND RUPTURING THE PAPILLARY MUSCLE, CAUSING PROLAPSE OF THE TV. COMBINED WITH THE PREVIOUSLY KNOWN PFO, THIS LED TO PATIENT OXYGEN DESATURATION. AFTER THE ABLATION PROCEDURE WAS COMPLETED, A PFO OCCLUDER WAS INSERTED INTO THE PFO TO PREVENT FURTHER DESATURATION. THE PATIENT MAY NEED VALVE REPAIR SURGERY IN THE FUTURE. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Low Oxygen Saturation; Regurgitation, Valvular; Respiratory Distress; Tricuspid Regurgitation

  MAUDE report 10532520 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00444. AT THE END OF A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE ABLATION PROCEDURE WAS COMPLETED WITH NO REPORTED ISSUES, BUT AT THE END OF THE PROCEDURE, AFTER ALL THE CATHETERS WERE REMOVED, 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 10462605 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION AND ATRIAL FLUTTER ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. TRANSSEPTAL ACCESS WAS GAINED TO THE LEFT ATRIUM AND THE ADVISOR VL WAS INSERTED. THERE WAS DIFFICULTY NAVIGATING AND MAPPING THE LEFT ATRIAL APPENDAGE. AFTER THE MAP WAS COMPLETED, A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED AND THE ABLATION CATHETER WAS INSERTED INTO THE LEFT ATRIUM. NOISE WAS OBSERVED ON THE DISTAL TIP OF THE ABLATION CATHETER AND IT WAS NOT LOCATING PROPERLY ON ENSITE. NO ABLATION WAS CONDUCTED. SHORTLY AFTER, THE PATIENT BECAME HYPOTENSIVE. A 2 CM PERICARDIAL EFFUSION WAS OBSERVED ON ICE. THE MAPPING CATHETER AND ABLATION CATHETERS WERE MOVED OUT OF THE LEFT ATRIUM. A PERICARDIAL TAP WAS PERFORMED WHICH STABILIZED THE PATIENT. THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT COUNT WAS DECREASING DESPITE DRAINING THE EFFUSION. A HEMATOMA WAS IDENTIFIED AT THE RIGHT GROIN SITE. THE HEMATOMA WAS CAUSED WHEN ACHIEVING VENOUS ACCESS AT THE BEGINNING OF THE PROCEDURE AND WAS NOT BELIEVED TO BE DUE TO AN ABBOTT DEVICE. A CT SCAN WAS ALSO PERFORMED AND RULED OUT RETROPERITONEAL BLEED. THE PATIENT WAS INTUBATED AND LEFT IN STABLE CONDITION. THE PHYSICIAN BELIEVES THE PERICARDIA

  Patient problems: Cardiac Perforation

  MAUDE report 10283104 ↗
• MalfunctionJul 9, 2020Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, THE DISTAL ELECTRODE WAS NOTED TO BE STUCK IN THE CHORDA TENDINEA AROUND THE TRICUSPID VALVE. THE CATHETER COULD NO LONGER BE OPERATED. THE CATHETER WAS REMOVED FROM THE PATIENT BY APPLYING TORQUE TO THE CATHETER SHAFT SEVERAL TIMES BUT THE LOOP WAS FOUND TO BE ELONGATED VERTICALLY. NO FURTHER INTERVENTION WAS NEEDED TO REMOVE THE DEVICE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254492 ↗