Advisor™ HD Grid, Sensor Enabled™ D-AVHD-DF16Recalls & reported problems

Summary

The FDA's MAUDE database contains 358 adverse event reports that list this exact device (DI 05415067028198), received between Jun 22, 2018 and Sep 24, 2026 — classified as 6 deaths, 118 injuries, 234 malfunctions.

The most frequently reported specific device problem is “Fracture” (67 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 25 most recent of 358 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  During the atrial fibrillation procedure, a cardiac tamponade requiring a thoracotomy was noted while performing left atrial mapping after transseptal puncture. Transseptal puncture was performed using a Swartz sheath and RF needle. An HD Grid catheter was inserted and left atrial mapping was being performed when the patients' blood pressure was noted to be dropping and a cardiac tamponade was confirmed via echocardiography. Hemostasis was achieved via a thoracotomy. The procedure was completed without replacing the device. The patient is stable and recovered.

  Patient problems: Cardiac Perforation

  MAUDE report 50885493 ↗
• InjuryAug 26, 2026Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Obstruction of Flow

  During a premature ventricular contraction procedure, leakage was observed from the intravenous line connected to the Advisor HD Grid mapping catheter and the flow of irrigation was obstructed. The physician suspected the presence of a blood clot after performing troubleshooting measures; however, this could not be definitively confirmed. The catheter was irrigated via gravity. The catheter was exchanged, and the procedure was completed with no adverse consequences to the patient.Based on the reported event information, the Advisor HD Grid Catheter was irrigated via gravity, which does not align with the instructions for use (IFU).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50459728 ↗
• MalfunctionApr 2, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE WITH A PROTRUDING COMPONENT FOUND IN THE CATHETER DURING INVESTIGATION. DURING THE LEFT VENTRICLE PVC PROCEDURE, AFTER THE CATHETER WAS INSERTED INTO THE LEFT VENTRICLE VIA THE TRANSAORTIC APPROACH, IT WAS NOTED THERE WAS NOISE PRESENT ON BOTH THE ENSITE X AND RECORDING SYSTEM. THE CABLES WERE RESEATED ON BOTH THE PROXIMAL AND DISTAL ENDS, BUT THE ISSUE WAS NOT RESOLVED. THE CABLE WAS THEN EXCHANGED, BUT THE ISSUE WAS STILL NOT RESOLVED. THE CATHETER WAS THEN EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764123 ↗
• MalfunctionDec 24, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  THIS REPORT IS TO ADVISE OF A PEELED CATHETER WITH MATERIAL DEFORMATION FOUND DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888581 ↗
• MalfunctionDec 23, 2025Peeled/Delaminated; Peeled/Delaminated

  THIS REPORT IS TO ADVISE OF PEELING FOUND ON THE CATHETER DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877666 ↗
• MalfunctionDec 17, 2025Peeled/Delaminated; Peeled/Delaminated

  AFTER THE PFA PROCEDURE FOR ATRIAL FIBRILLATION WAS COMPLETED USING NON-ABBOTT (BOSTON SCIENTIFIC) DEVICES, IT WAS NOTED THAT THE RUBBER COATING ON THE ADVISOR HD GRID CATHETER WAS TORN, AND THE WIRE CORE OF THE SPLINE WAS EXPOSED. THROUGHOUT THE PROCEDURE, BOTH PRE-ABLATION AND POST-ABLATION MAPPING WERE COMPLETED WITH NO ISSUES. THERE WAS NO RESISTANCE, TENSION, OR MANEUVERABILITY DIFFICULTIES NOTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826738 ↗
• MalfunctionDec 9, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A DELAY DUE TO MAGNETIC SENSOR ISSUES. BOTH THE SE SENSOR OF THE DIAGNOSTIC CATHETER AND ABLATION CATHETER WERE NOT RECOGNIZED. THERE WAS NO ISSUE WITH THE CONNECTION. THE POTENTIALS DISPLAYED BUT THE SE INDICATOR REMAINED RED AND THE SENSOR WAS NOT RECOGNIZED. BOTH THE CATHETERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763868 ↗
• MalfunctionDec 9, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A BEND WITH PROTRUDING INTERNAL COMPONENTS THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758348 ↗
• MalfunctionNov 18, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS NOTED DURING AN AF PROCEDURE THAT A SPLINE DISSOCIATED FROM THE GRID PANEL. WHEN THE PHYSICIAN WENT TO RETRACT THE ADVISOR HD GRID FROM THE PATIENT, SOME RESISTANCE WAS FELT AND ONE SPLINE WAS DISSOCIATED FROM THE GRID PANEL. THE ADVISOR HD GRID WAS ENTRAPPED WITH THE DECAPOLAR CATHETER (CORONARY SINUS). THE ADVISOR HD GRID WAS EXCHANGED WITH ANOTHER ADVISOR HD GRID AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584583 ↗
• InjuryNov 13, 2025Air/Gas in Device; Air/Gas in Device

  DURING A PFA ATRIAL FIBRILLATION PROCEDURE, AN ST SEGMENT ELEVATION AND HYPOTENSION OCCURRED, AND AIR WAS OBSERVED IN THE MAPPING CATHETER IRRIGATION LINE. THE CATHETER WAS REMOVED FROM THE PATIENT, AND THE LINE WAS FLUSHED. THE PROCEDURE CONTINUED, THE ST ELEVATION RESOLVED ON ITS OWN IN MINUTES, THE VITALS STABILIZED AND THE PROCEDURE WAS COMPLETED. THE PATIENT IS STABLE. AN IRRIGATED PRESSURE BAG WAS BEING USED. THE CAUSE OF THE AIR IN THE IRRIGATION LINE IS UNKNOWN.

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension

  MAUDE report 23550640 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE AF PROCEDURE, ST ELEVATION OCCURRED WHICH SELF-RESOLVED. WHILE TRANSSEPTAL WITH THE INTRODUCER, THE CATHETER WAS INSERTED, AND THE LEFT ATRIUM WAS MAPPED, BUT SOME ST SEGMENT ELEVATION WAS NOTED IN THE INFERIOR LEADS. AFTER WAITING TWO TO THREE MINUTES, THE ELEVATION RESOLVED ITSELF. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Arrhythmia

  MAUDE report 23547748 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  DURING THE AF PROCEDURE, WHEN MAPPING AFTER ABLATION IT WAS NOTED THAT THE CATHETER KEPT INDICATING THAT CATHETER WAS NOT UNSHEATHED MAKING MODELING INCONSISTENT WITH THE X-RAY IMAGES. THE CATHETER WAS EXCHANGED, AND MODELING COULD BE COMPLETED SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372852 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A PULSED FIELD ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, WITH THE ADVISOR HD GRID CATHETER IN THE ATRIUM FOR POST MAPPING, THE PATIENT SUDDENLY BECAME ARRESTED. CARDIAC MASSAGE HAD TO BE STARTED IMMEDIATELY AFTER USING THE VIEWMATE FOR THE ECHOCARDIOGRAM. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Arrest

  MAUDE report 23230544 ↗
• MalfunctionAug 28, 2025Signal Artifact/Noise; Difficult to Insert; Signal Artifact/Noise; Difficult to Insert

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION (AVRT), SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. THE ADVISOR HD GRID MAPPING CATHETER WAS PREPPED AND INSERTED THROUGH AN 8.5FR FAST-CATH HEMOSTASIS INTRODUCER, HOWEVER, DESPITE USING THE INSERTION TOOL DIFFICULTY PASSING THROUGH THE HEMOSTASIS VALVE WAS NOTED. WHEN THE CATHETER WAS FINALLY IN THE RIGHT ATRIUM, THE CATHETER APPEARED DISTORTED AND THE EGM SIGNALS WERE NOISY. THE CATHETER CONNECTOR CABLE WAS REPLACED BUT THIS DID NOT RESOLVE THE ISSUE. TROUBLESHOOTING WAS DONE ON THE "HORSETAIL", BUT THE PROBLEM STILL PERSISTED. THE CATHETER WAS REPLACED WITH ANOTHER ADVISOR HD GRID BUT EXPERIENCED THE SAME DIFFICULTY INSERTING THROUGH THE VALVE AND SAW THE SAME DISTORTION AND NOISY SIGNALS. THE SECOND ADVISOR HD GRID CATHETER WAS REPLACED WITH A FLEXIBILITY SE CATHETER AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912701 ↗
• MalfunctionAug 28, 2025Signal Artifact/Noise; Difficult to Insert; Signal Artifact/Noise; Difficult to Insert

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION (AVRT), SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. THE ADVISOR HD GRID MAPPING CATHETER WAS PREPPED AND INSERTED THROUGH AN 8.5FR FAST-CATH HEMOSTASIS INTRODUCER, HOWEVER, DESPITE USING THE INSERTION TOOL DIFFICULTY PASSING THROUGH THE HEMOSTASIS VALVE WAS NOTED. WHEN THE CATHETER WAS FINALLY IN THE RIGHT ATRIUM, THE CATHETER APPEARED DISTORTED AND THE EGM SIGNALS WERE NOISY. THE CATHETER CONNECTOR CABLE WAS REPLACED BUT THIS DID NOT RESOLVE THE ISSUE. TROUBLESHOOTING WAS DONE ON THE "HORSETAIL", BUT THE PROBLEM STILL PERSISTED. THE CATHETER WAS REPLACED WITH ANOTHER ADVISOR HD GRID BUT EXPERIENCED THE SAME DIFFICULTY INSERTING THROUGH THE VALVE AND SAW THE SAME DISTORTION AND NOISY SIGNALS. THE SECOND ADVISOR HD GRID CATHETER WAS REPLACED WITH A FLEXIBILITY SE CATHETER AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912019 ↗
• MalfunctionAug 21, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  DURING THE AT PROCEDURE, ONE OF THE SPLINES WAS FRACTURED WHEN BEING REMOVED FROM THE 8 FR SHEATH. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22869794 ↗
• MalfunctionAug 13, 2025Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method

  DURING A REDO ATRIAL FIBRILLATION PROCEDURE, THE CATHETER COULD NOT BE RETRACTED FROM THE SHEATH AFTER MAPPING THE RIGHT ATRIUM. WHEN VISUALIZED ON X-RAY, IT WAS OBSERVED THAT A NON ABBOTT (JNJ VISIGO) STEERABLE SHEATH HAD BEEN CAUGHT IN BETWEEN THE SPLINES OF THE HD GRID. THE HD GRID WAS ADVANCED TO FREE IT FROM THE SHEATH AND THE CATHETER WAS REMOVED FROM THE PATIENT. ONCE IT WAS REMOVED FROM THE SHEATH, IT WAS OBSERVED THAT THE SPLINES ON THE PADDLE HAD BEEN MISCONFIGURED. THE OPERATOR COMMENTED THAT THIS WAS DUE TO OPERATOR ERROR AND THE PADDLE BEING CAUGHT ON THE STEERABLE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792917 ↗
• MalfunctionJul 31, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IMPEDANCE AND OUTPUT ISSUES RESULTED IN A PROCEDURAL DELAY. FREQUENT "SURFACE ELECTRODE IMPEDANCE ERROR" MESSAGES BEGAN TO APPEAR SOMETIME AFTER VALIDATION. THE ALERT SCREEN DID NOT INDICATE WHICH PATCH WAS FAULTY. THE WIRING AND CONNECTIONS WERE CHECKED AND RECONNECTED, AND SEVERAL REVALIDATIONS WERE PERFORMED IN AN ATTEMPT TO CLEAR THE ALERT, BUT THE ISSUE PERSISTED. THE SYSTEM REFERENCE PATCH WAS REPLACED, AND THE IMPEDANCE ERROR WAS CLEARED. HOWEVER, DURING PRE-MAPPING IN NAVX MODE, INTERMITTENT NOISE BEGAN TO APPEAR ON THE RESPIRATION METER, WHILE THE VENTILATOR¿S CAPNOMETER REMAINED STABLE. THE PATCH CONNECTION WAS CHECKED. AT THE SAME TIME, THE CATHETER¿S NAVIGATION DISPLAY BECAME DISTORTED. BY THE END OF THE PRE-MAPPING, THE RESPIRATION METER WAS FILLED WITH NOISE, AND THE CATHETER¿S NAVIGATION DISPLAY CONTINUED TO MOVE ERRATICALLY. AS THE ISSUE COULD NOT BE RESOLVED, THE SYSTEM WAS SWITCHED TO VOXEL MODE AND THE ADVISOR HD GRID MAPPING CATHETER WAS EXCHANGED FOR THE ADVISOR HD GRID X CATHETER. THIS STABILIZED THE NAVIGATION DISPLAY, BUT THE RESPIRATION METER CONTINUED TO SHOW NOISE. MAPPING WAS CREATED IN VOXEL MODE, AND THE PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680319 ↗
• MalfunctionJul 31, 2025Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, THE CATHETER WAS LODGED IN THE SHEATH. THE MAPPING CATHETER WAS INSERTED INTO THE SHEATH AND ADVANCED INTO THE PATIENT. WHEN ATTEMPTING REMOVE THE CATHETER, IT SEEMED STUCK INSIDE THE SHEATH. IT WAS DISCOVERED THAT THE QUAD CATHETER WAS IN BETWEEN SPLINES OF THE MAPPING CATHETER AND WHEN IT WAS RETRACTED DOWN, IT WAS ABLE TO FREELY BE REMOVED; JUST A CHANGE IN CATHETER POSITIONING RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677429 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  AT THE END OF AN ATRIAL FIBRILLATION PFA PROCEDURE, THE SPLINES OF THE MAPPING CATHETER BROKE OFF. THE MAPPING CATHETER WAS BEING REMOVED FROM THE HEART AND RESISTANCE WAS NOTED. AFTER CONTINUING TO WITHDRAW THE CATHETER IT WAS FOUND THAT THE SPLINES HAD BROKEN OFF. THE PHYSICIAN ALLEGES THAT THE CAUSE MAY HAVE BEEN THE ICE CATHETER GOING THROUGH THE SPINES MAPPING CATHETER. FLUOROSCOPY CONFIRMED THAT NO PIECES WERE LEFT IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647116 ↗
• MalfunctionJul 29, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THIS REPORT IS TO ADVISE OF A DISPLACED ELECTRODE AND EXPOSED WIRE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642114 ↗
• MalfunctionJul 23, 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 22580520 ↗
• MalfunctionJul 21, 2025Material Twisted/Bent; Material Twisted/Bent

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER DURING ANALYSIS EXPOSING INTERNAL WIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555678 ↗
• MalfunctionJun 26, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336784 ↗
• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF AN EXPOSED WIRE DUE TO A DISPLACED ELECTRODE FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331720 ↗