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

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05415067049889), received between Mar 27, 2025 and Mar 11, 2026 — classified as 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Fluid/Blood Leak; Communication or Transmission Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE VALVE OF THE SHEATH. THE SHEATH WAS INSERTED THROUGH THE RIGHT GROIN AND ADVANCED INTO THE ATRIUM. AFTER THE GUIDEWIRE AND DILATOR WERE REMOVED, BLOOD LEAKAGE WAS OBSERVED FROM THE VALVE OF THE SHEATH. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571489 ↗
• MalfunctionMar 2, 2026Entrapment of Device

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE ADVISOR HD GRID X CATHETER BECAME ENTANGLED WITH THE ABLATION CATHETER. WHEN ATTEMPTING TO MOVE THE ADVISOR HD GRID X CATHETER TO THE RIPV, IT WOULD NOT MANEUVER. AT THIS TIME A MAGNETIC SENSOR ISSUE APPEARED. ON X-RAY, IT COULD BE SEEN THAT WHEN THE DIAGNOSTIC CATHETER WAS MOVED, SO WAS THE ABLATION CATHETER. THE ABLATION CATHETER WAS THEN PULLED BACK INTO THE SHEATH, FREEING IT FROM THE DIAGNOSTIC CATHETER. THE CATHETERS WERE SEPARATED AND THE ADVISOR HD GRID X CATHETER WAS REMOVED. THERE WERE NO WITHDRAWAL DIFFICULTIES NOTED ONCE SEPARATED. THE ADVISOR HD GRID X CATHETER WAS CHECKED AND NO VISIBLE DAMAGE WAS NOTED. THE DIAGNOSTIC CATHETER WAS THEN REINSERTED AND THE CABLES WERE RESEATED WITH NO RESOLUTION. THE ADVISOR HD GRID X 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 24492174 ↗
• MalfunctionFeb 3, 2026Fracture; Improper or Incorrect Procedure or Method

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER BECAME STUCK IN THE TIP OF THE NON-ABBOTT SHEATH (CORDIS 8F). THE SHEATH AND CATHETER HAD TO BE REMOVED TOGETHER. ONCE IT WAS REMOVED FROM THE PATIENT, THE TIP OF THE CATHETER WAS NOTED TO BE FRACTURED. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PHYSICIAN CONFIRMED NO PART OF THE CATHETER REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248372 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING A REDO ATRIAL FIBRILLATION AND ATRIAL TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED, RESULTING IN A PERICARDIOCENTESIS AND OPEN HEART SURGERY BEING PERFORMED. AFTER MAPPING THE LEFT AND RIGHT ATRIUM WITH THE ADVISOR HD GRID X CATHETER, THE TACTIFLEX WAS MOVED FROM THE LEFT TO THE RIGHT ATRIUM TO START ABLATION. BEFORE ANY ABLATION WAS DELIVERED IN THE HEART AT ALL, HYPOTENSION OCCURRED AND A PERICARDIAL EFFUSION WAS NOTED ON TRANS-ESOPHAGEAL ECHO. A PERICARDIOCENTESIS WAS STARTED WITH SOME EXTERNAL SHOCKS ADMINISTERED FOR VENTRICULAR TACHYCARDIA. AMIODARONE, PROTAMINE AND PLATELETS WERE ADMINISTERED. AS THE TAMPONADE WAS STILL NOT CONTROLLED, A DECISION WAS MADE TO OPEN THE CHEST BY THE SURGICAL TEAM. THE SURGICAL TEAM INVESTIGATED THE HEART, NO PERFORATION SITE WAS FOUND, AND THE BLEEDING WAS CONTROLLED SO NO INTERVENTION WAS NEEDED TO CONTROL THE TAMPONADE. AS THE PATIENT WAS SCHEDULED TO HAVE A REMINISCENT GAP CLOSURE ON A PREVIOUSLY CLOSED LEFT ATRIAL APPENDAGE, THIS WAS PERFORMED BY THE SURGICAL TEAM AT THIS TIME. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE AND SENT TO AN INTENSIVE CARE WARD FOR OBSERVATION AND RECOVERY. THE LOCATION AND CAUSE OF THE TA

  Patient problems: Cardiac Perforation

  MAUDE report 24111526 ↗
• MalfunctionDec 31, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING THE ATRIAL FIBRILLATION PROCEDURE IN VOXEL MODE, WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, THE WIRE ON THE B SPLINE WAS NOTED TO BE EXPOSED. THE CATHETER WAS USED FOR ABOUT TWO HOURS WITH NO ISSUES NOTED. BOTH THE ELECTRIC POTENTIALS AND THE POSITIONAL INFORMATION REMAINED NORMAL. THERE WAS NO NOTICEABLE RESISTANCE DURING INSERTION OR REMOVAL. THE ELECTRODES LOOKED INTACT AND THE WIRE UNBROKEN. THE PHYSICIAN DETERMINED THAT THERE WAS NO RISK OF ANY PART REMAINING INSIDE THE BODY, AND THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CATHETER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935095 ↗
• MalfunctionDec 29, 2025Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918770 ↗
• MalfunctionDec 22, 2025Entrapment of Device; Entrapment of Device

  DURING A PVI ATRIAL FIBRILLATION PROCEDURE, WHILE MAPPING, THE ADVISOR HD GRID X CATHETER BECAME CAUGHT IN THE TACTIFLEX ABLATION CATHETER WHICH WAS ABLE TO BE REMOVED WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863742 ↗
• MalfunctionDec 17, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER TRANSSEPTAL PUNCTURE, AN ECHOGENIC STRING-LIKE MATERIAL WAS SEEN ON THE TIP OF THE CATHETER IN THE LEFT ATRIUM VIA ICE. THIS WAS NOTED DIRECTLY AFTER ADVANCING THE CATHETER THROUGH THE SHEATH AND PRIOR TO ANY MAPPING. AT FIRST IT WAS ASSUMED TO BE A CLOT COMING FROM THE TIP OF THE GRID, HOWEVER THE ACT WAS WELL ABOVE THE SUGGESTED 300 SECONDS. THE CATHETER WAS CAREFULLY REMOVED FROM THE PATIENT WHILE ASPIRATING THE SHEATH. IT WAS CONFIRMED NOTHING WAS LEFT WITHIN THE LEFT ATRIUM VIA ICE. AFTER CLOSER INSPECTION OF THE CATHETER TIP OUTSIDE THE PATIENT, IT WAS CONFIRMED NOT TO BE A CLOT BUT STRAY THIN WIRING TANGLED AROUND THE TOP COUPLING JOINT OF THE CATHETER. IT WAS WRAPPED AROUND SEVERAL TIMES. THE WIRING WAS AS THIN AS A STRAND OF HAIR AND DIFFICULT TO SEE TO THE NAKED EYE. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFUL COMPLETED WITH NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831941 ↗
• MalfunctionDec 12, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, THERE WERE COMMUNICATION ISSUES WITH THE ADVISOR HD GRID X CATHETER AND THE TACTIFLEX ABLATION CATHETER RESULTING IN A DELAY. IT WAS NOTED THAT THE ADVISOR HD GRID X CATHETER COULD NOT BE VISUALIZED USING PORT 8 AND THAT A MAGNETIC SENSOR ERROR WAS DISPLAYED. THE CABLE WAS EXCHANGED, WITHOUT RESOLUTION. THE CATHETER WAS EXCHANGED AND CONNECTED INTO PORT 7 WHICH RESOLVED THE ISSUE. HOWEVER, THE TACTIFLEX CATHETER ALSO WAS NOT BEING RECOGNIZED AND DISPLAYED AN ERROR STATING "CATHETER NOT CONNECTED". THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786692 ↗
• InjuryNov 20, 2025Material Separation; Material Separation

  DURING THE PFA PROCEDURE, THE CATHETER TIP WAS DETACHED AND REMAINED IN THE PATIENT, REQUIRING THE USE OF A SNARE TO RETRIEVE THE COMPONENT. THE LEFT ATRIUM PRE-MAPPING WAS PERFORMED. AFTER INSERTION INTO THE LEFT SUPERIOR PULMONARY VEIN, AN ATTEMPT WAS MADE TO INSERT INTO THE LEFT INFERIOR PULMONARY VEIN, BUT THE CATHETER WOULD NOT ADVANCE. AT THAT TIME, THE PHYSICIAN NOTED A DISPLAY ABNORMALITY ON FLUOROSCOPIC IMAGING, THE AREA APPEARED TWISTED, AND ALSO ON ENSITE, ALL SPLINE #1 ELECTRODES OF THE CATHETER APPEARED TO BE STUCK TOGETHER. AN ATTEMPT WAS MADE TO RETRACT THE CATHETER INTO THE SHEATH, HOWEVER THE PADDLE TIP OF THE CATHETER BECAME STUCK AT THE SHEATH TIP AND COULD NOT BE PULLED BACK. WHEN THE PHYSICIAN FORCEFULLY PULLED THE CATHETER, THE TIP PORTION DETACHED AND FELL INTO THE LEFT ATRIUM. THE CATHETER WAS REPLACED, AND THE CASE WAS COMPLETED. SUBSEQUENTLY, A CT SCAN WAS PERFORMED TO LOCATE AND RETRIEVE THE DETACHED TIP. THE TIP WAS LOCATED NEAR THE ILIAC ARTERY, SO AN ATTEMPT WAS MADE TO RETRIEVE THE DETACHED TIP USING A SNARE VIA PUNCTURE OF THE LEFT FEMORAL ARTERY, BUT DUE TO BLOOD FLOW AND WIRE MANIPULATION, THE TIP MIGRATED FURTHER DISTALLY. AN ADDITIONAL PUNCTURE W

  Patient problems: Foreign Body In Patient

  MAUDE report 23605854 ↗
• MalfunctionNov 20, 2025Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  DURING PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE MAPPING CATHETER BECAME ENTRAPPED. WHEN MAPPING IT WAS ATTEMPTED TO NAVIGATE THE MAPPING CATHETER THROUGH THE AORTIC VALVE. THE CATHETER ENTERED THE LEFT VENTRICLE HOWEVER THERE WAS DIFFICULTY WITH THE CATHETER MANIPULATION AND IT WAS NOTED THERE WAS A LOSS OF DEFLECTION IN BOTH D AND F CURVES. IT WAS ATTEMPTED TO REMOVE THE CATHETER FROM THE SHEATH, BUT IT GOT STUCK AT THE HEMOSTASIS VALVE. AFTER SEVERAL ATTEMPTS THE CATHETER WAS REMOVED AND THE TIP WAS FOUND TO BE DEFORMED. THE MAPPING CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601709 ↗
• MalfunctionNov 9, 2025Entrapment of Device; Entrapment of Device

  DURING THE SUPRAVENTRICULAR TACHYCARDIA/ATRIAL VENTRICULAR PROCEDURE, AFTER MAPPING THE RIGHT ATRIUM, THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER THROUGH THE NON-ABBOTT SHEATH (VERSACROSS BY BOSTON SCIENTIFIC) BUT WAS UNABLE TO PULL THE CATHETER BACK INTO THE SHEATH. AFTER SOME TROUBLESHOOTING, THE PHYSICIAN DETERMINED THAT ONE OF THE OTHER DIAGNOSTIC CATHETERS HAD BECOME ENTANGLED IN THE SPLINES OF THE ADVISOR HD GRID X MAPPING CATHETER, PREVENTING IT FROM ENTERING THE SHEATH. THE PHYSICIAN WAS EVENTUALLY ABLE TO REMOVE ALL CATHETERS, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507281 ↗
• MalfunctionNov 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A SOFTWARE ISSUE WITH THE ENSITE X SYSTEM AND A COMMUNICATION ISSUE WITH THE ADVISOR HD CATHETER RESULTING IN A DELAY. AN HOUR INTO THE PROCEDURE, THE ENSITE X SUDDENLY FROZE AND THEN SHUT DOWN. THE ENSITE X SYSTEM WAS RESTARTED AND THE STUDY WAS RE-ENTERED, BUT IT IMMEDIATELY FROZE AGAIN AND SHUT DOWN. AFTER THE POWER OUTLET LOCATION WAS CHANGED AND IT WAS RESTARTED AGAIN, RF DELIVERY WITH THE ABLATION CATHETER WAS PERFORMED AND TAG WAS APPLIED SUCCESSFULLY. AT THAT TIME, A PRESET WAS NOT USED. AFTER CONNECTING THE CATHETER TO DRAW POST-MAP, IT FROZE AGAIN AND SHUT DOWN AFTER A WHILE. AFTER RESUMING THE STUDY, THE PROCEDURE WAS COMPLETED WITH ONLY THE ABLATION CATHETER WITHOUT USING THE ADVISOR HD CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453064 ↗
• MalfunctionOct 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, COMMUNICATION ISSUES RESULTED IN A DELAY IN PROCEDURE. THE CATHETER WAS INSERTED INTO THE CARDIAC CHAMBER AND CONNECTED TO THE DIRECT CONNECT CABLE, WHICH WAS THEN CONNECTED TO PORTS 6/8. HOWEVER, THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM. NO ERROR MESSAGE WAS DISPLAYED. TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING REPLACING THE DIRECT CONNECT CABLE, RESTARTING THE ENSITE AMP/DWS, DELETING AND RECREATING THE CATHETER PRESET, CHANGING THE CONNECTION PORTS TO 2/4 AND 5/7, SWITCHING THE MAIN POWER SOURCE, AND REVALIDATING THE SYSTEM. DESPITE THESE EFFORTS, THE CATHETER WAS STILL NOT RECOGNIZED. 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 23398115 ↗
• InjurySep 10, 2025Signal Artifact/Noise; Entrapment of Device; Material Separation; Signal Artifact/Noise; Entrapment of Device; Material Separation

  DURING COMPLEX FOCAL AT/LEFT FLUTTER ABLATION PROCEDURE, THE HD GRID X SPLINE DETACHED WHICH REQUIRED VASCULAR SURGEON INTERVENTION. IN THE BEGINNING OF THE PROCEDURE, THERE WAS NOISE ON INVOLVING ELECTRODE B1 ON THE RECORDING SYSTEM AND ON THE ENSITE X AFTER INSERTION OF THE GRID X. THE PHYSICIAN NOTED THAT THE GRID X INSERTION WAS DIFFICULT. THE CATHETER WAS USED THROUGHOUT THE PROCEDURE AND NOT REPLACED. THE PROCEDURE CONTINUED AND THERE WAS NO ADDITIONAL SIGNAL ISSUE ON B1. THROUGHOUT THE PROCEDURE WHICH WAS LONGER THAN EXPECTED (3 HOURS) THE PHYSICIAN WAS ABLE TO INSERT AND REMOVE THE CATHETER MULTIPLE TIMES WITH NO ISSUES. THERE WAS NO NOTED VISUAL DAMAGE AT THIS TIME. AT THE END OF THE PROCEDURE, THERE WAS DIFFICULTY TO REMOVE THE GRID X FROM THE SHORT INTRODUCER WHICH WAS IN THE RIGHT FEMORAL VEIN. FLUOROSCOPY WAS USED AND THE GRID X WAS ENTANGLED AT THE END OF THE INTRODUCER. A VASCULAR SURGEON WAS CONSULTED WHO THEN REMOVED THE CATHETER WITH FORCE. THIS DAMAGED THE CATHETER AND LEFT ONE OF THE SPLINES INSIDE THE FEMORAL VEIN. ANOTHER VASCULAR SURGEON WAS BROUGHT IN WHO WAS ABLE TO REMOVE THE SPLINE. HOWEVER, ONE OF THE ELECTRODES REMAINED IN THE PATIENT AND THE DECISION W

  Patient problems: Foreign Body In Patient

  MAUDE report 23015132 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, ST ELEVATION OCCURRED WHICH SELF RESOLVED. AFTER INSERTING THE MAPPING CATHETER INTO THE SHEATH, THE ST SEGMENT OF THE QRS WAS NOTED TO RISE FOR A SHORT TIME. AT THE END OF THE PROCEDURE, THE ST OF THE QRS HAD STABILIZED ON ITS OWN. IT IS UNKNOWN WHAT CAUSED THE ST ELEVATION AND THE PHYSICIAN DOES NOT ALLEGE ANY ABBOTT DEVICES CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Arrhythmia

  MAUDE report 22965874 ↗
• InjuryAug 21, 2025Difficult to Remove; Device Contamination with Body Fluid; Difficult to Remove; Device Contamination with Body Fluid

  THIS REPORT INCLUDES AN UPDATED ANALYSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22862275 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REDO ATRIAL FIBRILLATION, WHILE MAPPING WITH THE ADVISOR HD GRID X CATHETER, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. IT WAS DURING MAPPING THAT THE PATIENT BECAME HYPOTENSIVE. FLUOROSCOPY AND ULTRASOUND SHOWED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. IT IS UNKNOWN WHAT CAUSED THE PERICARDIAL EFFUSION HOWEVER THE PHYSICIAN ALLEGES IT OCCURRED DURING MAPPING OR PRIOR. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22805962 ↗
• MalfunctionMay 19, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A COMMUNICATION ISSUE OCCURRED CAUSING A PROCEDURE DELAY. THE ADVISOR HD GRID X CATHETER WAS INSERTED INTO AN AGILIS SHEATH AND WHEN AN ATTEMPT WAS MADE TO START MAPPING, THE CATHETER DID NOT CONNECT TO THE ENSITEX SYSTEM; THE CATHETER SHOWED RED ON THE SYSTEM AND NO SIGNALS WERE RECEIVED. THE ENTIRE ENSITE SYSTEM WAS RESTARTED AND A NEW ADVISOR HD GRID X WAS OBTAINED. THE PROCEDURE WAS THEN COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046797 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  AT THE END OF THE PROCEDURE, THE CATHETER DISCONNECTED AT THE FOURTH SPLINE. DURING THE PROCEDURE, THE CATHETER DID NOT COLLAPSE INTO SHEATH AT THE END OF THE CASE FOR REMOVAL. THEREFORE, THE SHEATH AND CATHETER WERE REMOVED TOGETHER. UPON REMOVAL, THE TIP OF MAPPING CATHETER WAS DISCONNECTED AT THE FOURTH SPLINE. NO ADVERSE EFFECTS OR VASCULAR EVENTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710517 ↗