Advisor™ D-AVSE-DF10-F15Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05415067025975), received between Jun 15, 2018 and Jan 27, 2026 — classified as 16 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, DURING GEOMETRY COLLECTION WITH AN ADVISOR FL CATHETER, THE PATIENT BECAME HYPOTENSIVE AND A CARDIAC TAMPONADE WAS NOTED ON ULTRASOUND. IT IS UNKNOWN HOW, WHEN, AND WHERE THE CARDIAC TAMPONADE OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABLE AT THE END OF PROCEDURE AND THE DAY AFTER. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 24190579 ↗
• InjuryDec 28, 2025Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL FIBRILLATION PROCEDURE, DURING THE LAST REMAP OF THE LEFT ATRIUM, THE MAPPING CATHETER BECAME CAUGHT IN LEAFLETS OF THE MITRAL VALVE OR CHORDAE. THE CATHETER WAS ABLE TO BE REMOVED WITH SOME MANEUVERS WITH NO APPARENT SIGNS OF INJURY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED PERFORMING THE LAST FEW RF APPLICATIONS WITH THE ABLATION CATHETER ON THE PULMONARY VEIN GAPS. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT SYMPTOMS. THE NEXT DAY, A HEART MURMUR WAS HEARD AND A LARGE REGURGITATION WAS NOTED ON ECHOCARDIOGRAM. IT IS THOUGHT THIS REGURGITATION WAS LIKELY DUE TO A BREAK OF A TENDINOUS CHORD. THE PATIENT IS ASYMPTOMATIC AND NO INTERVENTION HAS BEEN NEEDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23903537 ↗
• MalfunctionSep 15, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE IN THE CATHETER SHAFT NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053029 ↗
• MalfunctionMay 4, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING A PROCEDURE, WHEN INSERTING THE ADVISOR FL SE CATHETER INTO THE AGILIS INTRODUCER IT BECAME CURLED INTO THE IRRIGATION PORT. THE CATHETER WAS UNABLE TO BE RETRACTED SO FORCE WAS USED, RESULTING IN A PIECE OF THE CATHETER BREAKING OFF INSIDE THE INTRODUCER. THE INTRODUCER WAS THEN ALSO RETRACTED FROM THE PATIENT ALONG WITH ALL OTHER CATHETERS, AND THE SIDE PORT WAS EXAMINED. THE 10TH ELECTRODE OF THE ADVISOR CATHETER ATTACHED TO THE LOOP WIRE WAS EXCISED FROM THE SIDE PORT. THE PATIENT REMAINED STABLE DURING AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957666 ↗
• MalfunctionOct 5, 2023Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A DAMAGED ELECTRODE WAS NOTED. FOLLOWING INSERTION OF THE CATHETER INTO THE SHEATH, AN ABNORMALITY WAS NOTED AT THE HEAD END OF THE CATHETER ON THE THREE-DIMENSIONAL VIEW. UPON WITHDRAWAL OF THE CATHETER, A DAMAGED ELECTRODE WAS OBSERVED, SIMILAR TO A DETACHMENT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876513 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC TAMPONADE WAS DIAGNOSED VIA ECHOCARDIOGRAM. INITIALLY WHEN STARTING TO MAP THE LEFT ATRIUM OF THE PATIENT, THE PATIENT REPORTED PAIN AND MOVED. THE MAPPING CATHETER WAS ON THE POSTERIOR WALL OF THE LEFT ATRIUM BETWEEN THE TWO PULMONARY VEINS, SPECIFICALLY CLOSER TO THE INFERIOR PULMONARY VEIN, WHEN THE PAIN WAS REPORTED. AN ECHOCARDIOGRAM WAS THEN PERFORMED WHICH DIAGNOSED A PERICARDIAL EFFUSION. THE EFFUSION WAS DRAINED AND MEDICATION WAS ADMINISTERED TO REVERSE THE HEPARIN THE PATIENT INITIALLY RECEIVED. THEN PATIENT WAS THEN STABILIZED AND THE PROCEDURE WAS NOT CONTINUED. THERE WERE NO PATIENT SYMPTOMS. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 13598866 ↗
• MalfunctionJan 25, 2022Fracture; Fracture

  THIS REPORT IS BEING SUBMITTED BASED ON ANALYSIS WHICH REVEALED A FRACTURE IN THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342165 ↗
• MalfunctionOct 20, 2021Use of Device Problem; Communication or Transmission Problem; Use of Device Problem; Communication or Transmission Problem

  DURING AN AFIB PROCEDURE, WHEN THE CATHETER WAS PLUGGED IN FOR MAPPING IN THE LEFT ATRIUM, AN ERROR MESSAGE POPPED UP ON THE DWS THAT SAID ¿POSSIBLE CATHETER OR PORT ISSUE ERROR.¿ THE PORTS WERE SWITCHED AND THE PRECISION LINK WAS POWER CYCLED, BUT THE ISSUE PERSISTED. THE CATHETER CABLE WAS ALSO REPLACED WITH NO CHANGE IN ERROR STATUS. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS NOTED THAT THE DEVICE USED IN THE PATIENT WAS EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12664784 ↗
• MalfunctionAug 20, 2021Material Deformation; Material Deformation

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A DISPLACED ELECTRODE ON THE CATHETER WAS NOTED. WHEN THE CATHETER WAS INSERTED INTO THE SHEATH USING THE INSERTION TOOL, ONLY ABOUT HALF OF THE RING WAS INSERTED AND THEN IT COULD NOT BE INSERTED FURTHER. WHEN THE CATHETER WAS REMOVED, IT WAS NOTED THAT ONE OF THE RING ELECTRODES WAS SLIGHTLY SLANTED. THE CATHETER WAS REPLACED TO A NON-ABBOTT CATHETER AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12347342 ↗
• MalfunctionAug 9, 2021Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURE OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12296205 ↗
• MalfunctionJul 8, 2021Difficult to Insert; Difficult to Insert

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DISPLACED ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133892 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2021-00175, 3008452825-2021-00183. DURING A LEFT SIDED PULMONARY VEIN CONTRACTION PROCEDURE, A TAMPONADE OCCURRED. THE PATIENT BECAME HYPOTENSIVE, ADRENALINE WAS ADMINISTERED AND THE PATIENTS BLOOD PRESSURE INCREASED ONLY TRANSIENTLY. AN ECHO WAS REVEALED A CARDIAC PERFORATION AND THE PATIENT WAS TAKEN TO SURGERY, HOWEVER, THE SITE OF THE PERFORATION COULD NOT BE LOCATED. THE PATIENT IS RECOVERING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 11568508 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MFR NUMBERS: 2184149-2020-00228, 3008452825-2020-00714, 3005334138-2020-00643, 3008452825-2020-00715. THE DAY FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. THE EFFUSION WAS FOUND DURING POST-PROCEDURE TRANSTHORACIC ECHOCARDIOGRAPHY PERFORMED ONE DAY AFTER THE PROCEDURE. THE LOCATION OF THE PERFORATION WAS NOT KNOWN. PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ALLEGATIONS AGAINST ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 11132727 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2020-0723, 3008452825-2020-00724, 3005334138-2020-00646, 3008452825-2020-00726. TWO DAYS POST ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAPHY. SEROHEMATIC FLUID WAS DRAINED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 11060862 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2019-00529, 3008452825-2019-00530, 3005334138-2019-00586, 3008452825-2019-00540. FOLLOWING COMPLETION OF THE PROCEDURE, THE PATIENT SHOWED SIGNS OF HEMIPLEGIA. LESS THAN 15 MINUTES LATER THE PATIENT HAD NO FURTHER SYMPTOMS AND MAGNETIC RESONANCE IMAGING (MRI) WAS NEGATIVE FOR A CEREBROVASCULAR ACCIDENT (CVA). NO INTERVENTION WAS NEEDED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 9309267 ↗
• InjuryAug 21, 2019Use of Device Problem; Use of Device Problem

  AN EXPIRED CATHETER WAS OPENED AND USED FOR A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914897 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00366, 3008452825-2019-00369, 3008452825-2019-00370, 3005334138-2019-00438, 3008452825-2019-00372. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. DURING MANIPULATION IN THE LEFT ATRIUM AND PULMONARY VEINS, THE PATIENT EXPERIENCED CHEST PAIN, DECOMPRESSION SICKNESS AND THEIR BLOOD PRESSURE DROPPED. A CARDIAC ECHO CONFIRMED A BLOOD LEAK TO THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. MEDICATION WAS ADMINISTERED TO INCREASE BLOOD PRESSURE AND THE PATIENT WAS DISCHARGED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 8876413 ↗
• InjuryAug 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PULMONARY VEIN ISOLATION PROCEDURE A DEVICE FRAGMENTATION OCCURRED. THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM (LA) VIA A 9F INTRODUCER WITH MINIMAL RESISTANCE AND AFTER THE LA MODEL WAS COMPLETED THE CATHETER WAS SMOOTHLY RETRACTED INTO THE SHEATH FOR REMOVAL. THOUGH NO RESISTANCE WAS NOTED IT APPEARED THAT PART OF THE CATHETER HAD DETACHED WHEN IT WAS RETRACTED BACK INTO THE SHEATH. WHEN THE CATHETER WAS OUTSIDE OF THE BODY IT WAS CONFIRMED THE END WITH THE ELECTRODES WAS MISSING. A NEW CATHETER WAS INTRODUCED INTO THE PATIENT THROUGH THE LEFT FEMORAL VEIN TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT HOWEVER THE DETACHED PORTION OF THE CATHETER REMAINS WITHIN THE PATIENT WITH PLANS TO REMOVE IN A COUPLE MONTHS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8871696 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00209, 3008452825-2019-00212, 3008452825-2019-00213, 3005334138-2019-00233. FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION WAS OBSERVED. THE PATIENT WAS EXTERNALLY CARDIOVERTED TO RESTORE SINUS RHYTHM AND AFTERWARDS BECAME HYPOTENSIVE. ULTRASOUND IMAGING 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 8560122 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2019-00031, 3008452825-2019-00033, 3008452825-2019-00034, 3005334138-2019-00048. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING THE ABLATION, AT THE END OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE LOCATION OF THE EFFUSION REMAINS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 8296270 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2018-00491, 3008452825-2018-00413. AT THE END OF AN ATRIAL FIBRILLATION PROCEDURE, A TAMPONADE OCCURRED. FOLLOWING THE PROCEDURE, PRIOR TO THE PATIENT WAKING UP, THE PATIENT BECAME HYPOTENSIVE AND A TRANSESOPHAGEAL ECHO REVEALED A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 8160354 ↗
• InjuryOct 3, 2018Entrapment of Device; Entrapment of Device

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE DEVICE BECAME ENTANGLED NEAR THE PATIENT'S MITRAL VALVE. THE CATHETER WAS ADVANCED VIA ANTEGRADE APPROACH AND MAPPING BEGAN IN THE LEFT ATRIUM. WHILE MAPPING, THE CATHETER BECAME ENTANGLED IN THE PATIENT'S MITRAL VALVE. OPEN CHEST SURGERY WAS REQUIRED IN ORDER TO AVOID DAMAGING THE MITRAL VALVE OR CHORDAE TENDINEAE DURING PERCUTANEOUS REMOVAL OF THE CATHETER. THE CATHETER TIP WAS CUT AND THE REMAINDER OF THE CATHETER WAS REMOVED FROM THE SHEATH WHILE THE CATHETER TIP WAS SUCCESSFULLY EXTRACTED AND THERE WAS NO DAMAGE TO THE MITRAL VALVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT CATHETER AND THE PATIENT IS IN STABLE CONDITION. THE PHYSICIAN FELT THE CAUSE WAS PROCEDURE RELATED AND NOT DUE TO A PERFORMANCE ISSUE WITH ANY ABBOTT DEVICE.

  Patient problems: No Code Available

  MAUDE report 7931374 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 9680001-2018-00103, 3008452825-2018-00229. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. WHEN ABLATING THE LEFT PULMONARY VEINS THE PATIENT'S HEART APPEARED TO NOT MOVE CORRECTLY ON FLUOROSCOPY. AN ECHOCARDIOGRAM WAS PERFORMED REVEALING THE PERICARDIAL EFFUSION. NO INTERVENTION WAS REQUIRED AND THE PATIENT REMAINED IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 7674724 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3005334138-2018-00190, 2030404-2018-00050, 3005334138-2018-00199, 3005334138-2018-00200. FOLLOWING AN ABLATION PROCEDURE, A SPASM OCCURRED. A PARDEE WAVE WAS NOTED ON THE ECG DUE TO THE SPASM OF THE RIGHT CORONARY ARTERY, AFTER ALL DEVICES WERE WITHDRAWN FROM THE HEART. THE SPASM WAS DIAGNOSED VIA ANGIOGRAPHY. THE PROCEDURE WAS ABLE TO BE COMPLETED AND THE PATIENT WAS STABLE WITH NO SYMPTOMS. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Arrhythmia

  MAUDE report 7673002 ↗
• MalfunctionJun 15, 2018Detachment Of Device Component; Detachment Of Device Component

  DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, RESISTANCE WAS NOTED WHEN INSERTING THE CATHETER AND THE DEVICE COULD NOT BE ADVANCED PAST THE HEMOSTASIS VALVE OF THE SHEATH. UPON REMOVAL FROM THE PATIENT, THE DISTAL ELECTRODE WAS SEPARATED FROM THE CATHETER. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES ONTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604810 ↗