AdvisorRecalls & reported problems across all models

We found 4 models of Advisor by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Jan 27, 2026 — classified as 1 death, 30 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Advisor problems

Advisor models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Advisor™ D-AVSE-DF10-F15

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  25 reports
• Advisor™ D-AVSE-D10-F15

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  13 reports
• Advisor™ D-AVSE-D10-F20

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 death10 reports
• Advisor™ D-AVSE-DF10-F20

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  10 reports

Recent Advisor adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 11, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356744 ↗
• MalfunctionJul 26, 2024Fracture; Material Deformation; Fracture; Material Deformation

  THIS REPORT IS TO ADVISE OF A FRACTURE AND DISPLACED ELECTRODES FOUND ON THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840967 ↗
• MalfunctionFeb 26, 2024Signal Artifact/Noise; Expiration Date Error; Signal Artifact/Noise; Expiration Date Error

  ADDITIONAL INFORMATION RECEIVED ON 3/28/24 CONFIRMED THE CORRECT LOT NUMBER IS 8622315 AND THE CORRECT EVENT DATE WAS OCTOBER 21, 2023. THE EXPIRATION DATE OF THIS LOT WAS JANUARY 31, 2024 AND WAS THEREFORE NOT EXPIRED AT THE TIME OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778608 ↗
• MalfunctionFeb 16, 2024Fracture; Fracture

  THIS REPORT IS TO ADVISE OF CATHETER FRACTURES NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722192 ↗
• MalfunctionFeb 1, 2024Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF A DISPLACED ELECTRODE FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625574 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS. AFTER LEFT PULMONARY VEIN ISOLATION THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAPHY CONFIRMED A PERICARDIAL EFFUSION AROUND THE RIGHT AND LEFT HEART CAVITIES. THE PROCEDURE WAS STOPPED, AND THE PERICARDIAL EFFUSION WAS DRAINED BY PERCUTANEOUS PUNCTURE, WHICH STABILIZED THE PATIENT. IT IS UNKNOWN WHAT CAUSED THIS PERICARDIAL EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 18547465 ↗
• 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 ↗
• MalfunctionSep 30, 2023Material Separation; Material Separation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE ADVISOR FL MAPPING CATHETER WAS USED FOR POST CRYO ABLATION MAPPING. THE ADVISOR FL MAPPING CATHETER WAS INSERTED IN A SWARTZ BRAIDED INTRODUCER AND THEN IT WAS INSERTED INTO A NON-ABBOTT SHEATH (MEDTRONIC FLEXCATH) TO PERFORM MAPPING. THE ADVISOR FL MAPPING CATHETER WAS THEN INSERTED BACK INTO THE SWARTZ BRAIDED INTRODUCER. WHEN THE ADVISOR FL MAPPING CATHETER WAS REMOVED FROM THE PATIENT'S BODY, THE CATHETER COATING WAS BROKEN AND THE LEAD WIRE WAS EXPOSED. THE ADVISOR FL MAPPING CATHETER WAS REPLACED AND SINCE THE DAMAGED CAPSULE REMAINED IN THE SWARTZ BRAIDED INTRODUCER, IT WAS ALSO REPLACED. THE PROCEDURE THEN PROCEEDED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WERE NO ALLEGED ISSUES WITH THE SWARTZ BRAIDED INTRODUCER. A POST-OPERATIVE MRI WAS COMPLETED, AND NO RESIDUAL FINDINGS WERE FOUND IN THE CEREBRAL BLOOD VESSELS. ALTHOUGH IT CANNOT BE SURE, FOUND THAT WHAT APPEARED TO BE REMNANTS IN THE RIGHT ATRIUM. THE PATIENT IS CURRENTLY UNDER FOLLOW-UP OBSERVATION. A CHECK OF THE SHEATH AT THIS TIME REVEALED NO EXTERNAL DAMAGE. THERE WAS NO RESISTANCE DURING THE PROCEDURE, AND THE USER DID NOT FORCE THE OPERATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17849323 ↗
• MalfunctionJul 14, 2023Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE ADVISOR HD GRID CATHETER BECAME ENTANGLED WITH THE ADVISOR FL IN THE LEFT ATRIUM AND THE CATHETERS COULD NOT BE REMOVED. WHEN ATTEMPTING TO REMOVE THE CATHETERS USING A SNARE, A ATRIAL SEPTAL DEFECT DEVELOPED UPON EXITING THE RIGHT ATRIUM AND THE CATHETERS WERE SUCCESSFULLY REMOVED USING AN ABLATION CATHETER. PULMONARY VEIN ISOLATION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WHICH TOOK APPROXIMATELY 2 HOURS LONGER THAN USUAL. THE CATHETERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17324687 ↗
• 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 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
• Proclaim12 models · 35,038 reports · 17 recalls
• Durata28 models · 19,805 reports
• Assurity MRI2 models · 17,838 reports · 1 recall
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls