Sphere-9™ Catheter AFR-00001 (UDI 00763000973391)Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00763000973391), received between Jan 17, 2025 and May 29, 2026 — classified as 3 deaths, 73 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (24 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 11, 2026Class IIOpen, Classified

   Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.

   Z-1948-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A CARDIAC ABLATION PROCEDURE, WHEN THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CONCERN FOR REDDISH-BROWN URINE. DIAGNOSTIC TEST RESULTS INDICATED ACUTE KIDNEY INJURY. THE PATIENT WAS RECOMMENDED TO HYDRATE WITH INTRAVENOUS FLUIDS FOR TREATMENT AND RECEIVED A ONE-TIME 1 L DOSE OF INTRAVENOUS FLUIDS, THEN WAS DISCHARGED HOME WITH A PLAN TO FOLLOW UP IN 2¿3 DAYS. THE ACUTE KIDNEY INJURY WAS REPORTED AS RECOVERED/RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Kidney injury

  MAUDE report 25334257 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK FOLLOWING AN INDEX ABLATION PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH FATIGUE, PALPITATIONS, AN IRREGULAR PULSE OF 122, AND EFFORT INTOLERANCE ATTRIBUTABLE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. A 12-LEAD ELECTROCARDIOGRAM CONFIRMED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE PATIENT HAD A NEW HOSPITALIZATION FOR THIS EVENT AND RECEIVED AN INTRAVENOUS POTASSIUM CHANNEL BLOCKER LOADING DOSE OVER 24 HOURS, FOLLOWED BY POTASSIUM CHANNEL BLOCKER 200 MG TWICE DAILY FOR ONE WEEK AND THEN 200 MG ONCE DAILY. ELECTRICAL CARDIOVERSION WAS PERFORMED SUCCESSFULLY, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH THE OUTCOME REPORTED AS RECOVERING/RESOLVING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Atrial Fibrillation; Fatigue; Palpitations

  MAUDE report 25334194 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AFFERA MAPPING SYSTEM WITH A SPHERE 9 CATHETER WAS USED DURING A VENTRICULAR TACHYCARDIA ABLATION, TWO VENTRICULAR TACHYCARDIA MORPHOLOGIES WERE INDUCED WITH SUSPECTED ORIGIN FROM THE INFERIOR SEPTUM OF THE LEFT VENTRICLE, AND PREMATURE VENTRICULAR CONTRACTIONS WERE DESCRIBED AS A SUSPECTED TRIGGER FOR VENTRICULAR TACHYCARDIA OR VENTRICULAR FIBRILLATION. A SCAR MAP WAS CREATED DURING RIGHT VENTRICULAR LEAD PACING AND LEFT VENTRICULAR SCAR HOMOGENIZATION WAS PERFORMED ON THE INFERIOR AND SEPTAL WALLS, INCLUDING LESION DELIVERY AT THE INFERIOR BASAL SEPTUM AND AT THE LEFT POSTERIOR FASCICLE BASED ON MAPPED SIGNALS INCLUDING PURKINJE POTENTIALS. PULSED FIELD ABLATION AND RADIOFREQUENCY ABLATION LESIONS WERE DELIVERED, AND COMPLETE TYPE 3 HEART BLOCK WAS LATER RECOGNIZED AFTER ABLATION PERFORMED UNDER LEFT VENTRICULAR PACING, WITH A CONCERN THAT THE POSTERIOR FASCICLE MAY HAVE BEEN THE ONLY REMAINING CONDUCTION PATHWAY. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA AFTER RECOGNITION OF COMPLETE HEART BLOCK, AND ANOTHER MANUFACTURER'S BIVENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HA

  Patient problems: Heart Block

  MAUDE report 25228811 ↗
• MalfunctionMay 12, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE A STEAM POP OCCURRED DURING THE SEVENTH LESION OF THE CAVOTRICUSPID ISTHMUS LINE. THE CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE PROCEDURE CONTINUED. THE OUTCOME OF THIS CASE IS UNKNOWN. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148217 ↗
• MalfunctionMay 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE WHILE DELIVERING RADIOFREQUENCY ABLATION OF THE CAVOTRICUSPID ISTHMUS (CTI) LINE, A STEAM POP OCCURRED. THE PROCEDURE CONTINUED WITH A REPLACEMENT DEVICE. IT WAS REPORTED THAT THERE WAS NO CHAR, TISSUE, OR DAMAGE OBSERVED ON THE CATHETER. THE OUTCOME OF THIS CASE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096459 ↗
• MalfunctionApr 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING CARDIAC PROCEDURE, DURING USE OF THE SPHERE 9 CATHETER DURING A CARDIAC ABLATION APPLICATION ON THE ANTERIOR MITRAL LINE, THE PHYSICIAN HEARD AND FELT A STEAM POP AND THE ABLATION WAS STOPPED IMMEDIATELY. AN ULTRASOUND CHECK FOR EFFUSION WAS PERFORMED AND NO EFFUSION WAS CONFIRMED, AFTER WHICH THE PROCEDURE CONTINUED WITHOUT ISSUE. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967106 ↗
• InjuryApr 15, 2026Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT POST-OPERATIVELY TO A COMPLETED CARDIAC ABLATION PROCEDURE, REPORTED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED AND DISCHARGED HOME TWO DAYS LATER. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2026: IT WAS LATER REPORTED THAT THE CARDIAC ABLATION PROCEDURE WAS TWO DAYS PRIOR TO THE PATIENT REPORTING TO THE HOSPITAL WITH ABDOMINAL PAIN. (B)(6) 2025: IT WAS LATER REPORTED THAT TWO CONSECUTIVE STEAM POPS OCCURRED INTRAOPERATIVELY A CARDIAC ABLATION PROCEDURE. THE CATHETER WAS REMOVED AND CHAR/THROMBUS FORMATION WAS OBSERVED ON THE CATHETER. THE CATHETER WAS REPLACED. ANOTHER STEAM POP OCCURRED. AS A RESULT OF ABLATION THIS AREA, THE PATIENT DEVELOPED LEFT BUNDLE BRANCH BLOCK (LBBB). A TRANSESOPHAGEAL ECHOCARDIOGRAM AND CHEST X-RAY WERE PERFORMED.

  Patient problems: Abdominal Pain; Heart Block; Pulmonary Edema

  MAUDE report 24890771 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, FOLLOWING THE FINAL ABLATION OF THE RIGHT PULMONARY VEINS, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PULSE RATE DECREASED INTO THE LOW 40S. INTRACARDIAC ECHOCARDIOGRAPHY SHOWED A PERICARDIAL EFFUSION, AND TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED WHAT APPEARED TO BE A SMALL EFFUSION. TEMPORARY PACING WAS ATTEMPTED TO ASSESS WHETHER THE LOW PULSE RATE WAS CONTRIBUTING TO THE BLOOD PRESSURE DROP, AND PACING SLIGHTLY IMPROVED BLOOD PRESSURE; A TEMPORARY PACING LEAD WAS INSERTED VIA THE RIGHT INTERNAL JUGULAR VEIN. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 300 CC OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE, AND ANTICOAGULATION WAS REVERSED WITH 75 MG OF AN ANTICOAGULANT ANTAGONIST. THE ACTIVATED CLOTTING TIME (ACT) WAS THERAPEUTIC PRIOR TO AND DURING PROCEDURE. THE PROCEDURE WAS COMPLETED. THE PATIENT STABILIZED AND WAS SENT TO THE POST-ANESTHESIA CARE UNIT WITH A TEMPORARY PACEMAKER IN THE RIGHT INTERNAL JUGULAR VEIN AND A NEGATIVE PRESSURE BAG ATTACHED TO THE PERICARDIAL DRAIN AND WAS ADMITTED FOR OVERNIGHT OBSERVATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24876791 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY AN INDEX PROCEDURE USING THE SPHERE-9 CATHETER, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION REOCCURRENCE DOCUMENTED ON ELECTROCARDIOGRAMS, INCLUDING RECURRENCE AFTER ELECTRICAL CARDIOVERSION. THE PATIENT PRESENTED TO THE CARDIAC LAB UNIT FOR TRANSESOPHAGEAL ECHOCARDIOGRAPHY AND ELECTRICAL CARDIOVERSION, AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED NO LEFT ATRIAL APPENDAGE THROMBUS; AN EP STUDY WAS PERFORMED AND CARDIOVERSION RETURNED THE RHYTHM TO SINUS RHYTHM, BUT ATRIAL FIBRILLATION RECURRED APPROXIMATELY 30 MINUTES LATER, AND THE PATIENT WAS DISCHARGED THE SAME DAY. ORAL ANTI-ARRYTHMIC MEDICATION WAS INITIATED FOR ATRIAL FIBRILLATION RECURRENCE. THE PATIENT LATER RETURNED FOR ADDITIONAL ELECTRICAL CARDIOVERSIONS WITH 200J EXTERNAL BIPHASIC ENERGY, WITH RETURN TO SINUS RHYTHM FOLLOWED BY RECURRENCE OF ATRIAL FIBRILLATION MINUTES LATER, AND SINUS BRADYCARDIA WAS ALSO DOCUMENTED ON ELECTROCARDIOGRAM; ORAL BETA-BLOCKER MEDICATION WAS DISCONTINUED. A SUBSEQUENT CARDIOVERSION FOR RECURRENT ATRIAL FIBRILLATION AGAIN RETURNED THE RHYTHM TO SINUS RHYTHM, AND ELECTROCARDIOGRAMS DOCUMENTED ATRIAL FIBRILLATION AND SINUS BRADYCARDIA. THE EVENTS WERE REPOR

  Patient problems: Atrial Fibrillation; Bradycardia

  MAUDE report 24830870 ↗
• MalfunctionApr 7, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, HEPARIN WAS ADMINISTERED AND THE CATHETER WAS INTRODUCED APPROXIMATELY 90 SECONDS LATER. CAVOTRICUSPID ISTHMUS ABLATION WAS PERFORMED, AND THE CATHETER WAS THEN REMOVED FROM THE BODY TO PROCEED WITH A TRANSSEPTAL APPROACH; UPON REMOVAL, CLOTS WERE FOUND IN THE CATHETER LATTICE. THE CATHETER WAS REPLACED. ACTIVATED CLOTTING TIME WAS MEASURED AT 343 PRIOR TO PROCEEDING WITH A NEW CATHETER. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800410 ↗
• MalfunctionApr 7, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, WHEN THE CATHETER WAS REMOVED FROM THE RIGHT ATRIUM TO PREPARE FOR TRANSSEPTAL ACCESS, CLOTS WERE NOTICED IN THE CATHETER LATTICE. ACTIVATED CLOTTING TIME WAS MEASURED AT 337 AT THE TIME THE CATHETER WAS REMOVED FROM THE BODY. THE CATHETER WAS REPLACED. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799613 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT'S ORAL ANTICOAGULATION MEDICATION WAS WITHHELD A DAY PRIOR TO THE PROCEDURE, AND THAT THE PATIENT HAD A COMPUTERIZED TOMOGRAPHY (CT) SCAN PRIOR TO BEGINNING OF THE PROCEDURE TO RULE OUT THROMBUS.

  Patient problems: Stroke/CVA

  MAUDE report 24743861 ↗
• MalfunctionMar 30, 2026Contamination

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, TISSUE WAS NOTED ON THE SPHERE CATHETER AFTER REMOVAL. THE NON-MEDTRONIC SHEATH WAS FLUSHED AND NO OTHER DEBRIS WAS NOTED. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24733833 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, PERICARDIAL EFFUSION WAS NOTED BEFORE TRANSSEPTAL PUNCTURE AND WORSENED AFTER THE TRANSSEPTAL PUNCTURE. CARDIAC TAMPONADE OCCURRED, AND THE PATIENT EXPERIENCED CONTINUED BLEEDING INTO THE PERICARDIUM. AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS USED FOR MONITORING THE EFFUSION. THE PHYSICIAN PROCEEDED WITH THE ABLATION, INSERTING THE CATHETER AND PERFORMING PULMONARY VEIN ISOLATION, FLOOR, AND ROOF LINES. PERICARDIOCENTESIS WAS PERFORMED, FLUID WAS REMOVED, AND PATIENT MONITORING CONTINUED. ADDITIONAL FLUID WAS REMOVED FROM THE PERICARDIUM DUE TO ONGOING BLEEDING, AND CARDIOTHORACIC SURGERY WAS CONSULTED. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24712798 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE ELECTRODE P3 ON THE CATHETER SHOWED A CONSTANT HIGH TEMPERATURE READING AFTER THE DEVICE WAS REMOVED AND REINSERTED INTO ANOTHER MANUFACTURER'S TRANSEPTAL SHEATH, AND FOLLOWING CARDIOVERSION POST LEFT ATRIAL ABLATIONS IN RESPONSE TO ATRIAL FIBRILLATION (AF). TROUBLESHOOTING WAS PERFORMED, INCLUDING TRYING A NEW ABLATION CABLE, WHICH DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REPLACED TO COMPLETE THE RIGHT ATRIAL CAVO-TRICUSPID ISTHMUS (CTI) ABLATION, WITH NO FURTHER ISSUES REPORTED. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 24689313 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING USE OF THE AFR-00016 IMPEDANCE MAPPING SYSTEM AND THE SPHERE 9 CATHETER IN A CARDIAC ABLATION PROCEDURE, THE MAPPING SYSTEM EXPERIENCED A SOFTWARE ISSUE WHERE A LABELED TAG WAS DROPPED INSTEAD OF THE INTENDED ELECTRICAL TAG, A DELAY IN EXECUTING THE FAST REMAP FUNCTION, A GENERATOR CENTRAL PROCESSING UNIT (CPU) HIGH USAGE ALERT, AND A DELAY IN FAST REMAP. THE F5 FUNCTION BROUGHT UP A WINDOW THAT OBSTRUCTED THE SCREEN, THE MOUSE WHEEL WAS UNABLE TO SCROLL IN DROP-DOWN MENUS, AND THE "ADD TAG TO ANATOMY" OPTION WAS NO LONGER AVAILABLE. ADDITIONALLY, PULSE3 COMMENTED ON EVERY PULSE FIELD LESION, BLOCKING USEFUL TAGGING. WHILE ABLATING ON THE INFERIOR VENA CAVA (IVC) SIDE OF THE RIDGE DURING RADIOFREQUENCY ABLATION OF THE CAVOTRICUSPID ISTHMUS (CTI), A STEAM POP WAS IDENTIFIED BY THE PHYSICIAN, WHO COULD FEEL, SMELL, AND SEE THE EVENT ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE LESION GRAPH INDICATED A DROP IN TEMPERATURE AND A SPIKE IN CURRENT HALFWAY THROUGH THE ABLATION. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676388 ↗
• MalfunctionMar 24, 2026

  TEMP SENSOR ERROR / NO PT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673359 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST CARDIAC ABLATION PROCEDURE, THE PATIENT EXPERIENCED RECURRENCE OF ATRIAL FIBRILLATION, IRREGULAR HEART RHYTHM AS INDICATED BY A BLOOD PRESSURE CUFF, ELEVATED HEART RATES IN THE 90S-100S (WITH THE PATIENT'S NORMAL SINUS RHYTHM TYPICALLY IN THE 50S), SHORTNESS OF BREATH, AND DYSPNEA ON EXERTION. ELECTROCARDIOGRAMS CONDUCTED ON TWO SEPARATE DATES CONFIRMED ATRIAL FIBRILLATION, AND A SUBSEQUENT ELECTROCARDIOGRAM SHOWED A RETURN TO SINUS RHYTHM. ELECTRICAL CARDIOVERSION WAS PERFORMED, RESULTING IN SUCCESSFUL RESTORATION OF NORMAL SINUS RHYTHM. THE PATIENT WAS DISCHARGED HOME THE SAME DAY WITH NO CHANGES TO HOME MEDICATIONS. THE OUTCOME WAS REPORTED AS RECOVERED/RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Atrial Fibrillation; Dyspnea; Tachycardia

  MAUDE report 24665044 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A POST-OPERATIVE FOLLOW-UP VISIT AFTER AN INDEX PROCEDURE, A SUBJECT REPORTED COMPLAINTS OF FEELING HOT AND SWEATY, AND THAT HER SMARTWATCH SHOWED THAT SHE WAS IN ATRIAL FIBRILLATION. AN ELECTROCARDIOGRAM CONFIRMED ATRIAL FIBRILLATION,AND THE SUBJECT WAS ADVISED TO CALL THE OFFICE IF SYMPTOMS PERSISTED. THE FOLLOWING DAY, THE SUBJECT REPORTED CONTINUED ATRIAL FIBRILLATION, PROMPTING THE SCHEDULING OF AN ELECTRICAL CARDIOVERSION, WHICH RESTORED NORMAL SINUS RHYTHM. THE SUBJECT WAS DISCHARGED THE SAME DAY WITH NO CHANGES TO MEDICATIONS. ELECTROCARDIOGRAMS PERFORMED SHOWED ATRIAL FIBRILLATION AND SUBSEQUENT SINUS RHYTHM. THE OUTCOME WAS REPORTED AS RECOVERED/RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Diaphoresis

  MAUDE report 24664658 ↗
• InjuryMar 19, 2026No Apparent Adverse Event

  IT WAS LATER REPORTED THAT THE STEAM POP OCCURRED ON THE INFERIOR VENA CAVA SIDE OF THE CAVOTRICUSPID ISTHMUS (CTI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645773 ↗
• MalfunctionMar 19, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE FIRST CATHETER EXPERIENCED AN ELECTRODE ISSUE AND STOPPED READING. THE CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE SECOND CATHETER WAS ASSOCIATED WITH A STEAM POP WITH RADIOFREQUENCY (RF) ON THE CAVOTRICUSPID ISTHMUS (CTI). THE PROCEDURE WAS TEMPORARILY INTERRUPTED BUT WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639707 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, DELAYED TRANSIENT ST SEGMENT DEPRESSION WAS OBSERVED DURING POST MAPPING, APPROXIMATELY 13 MINUTES AFTER THE LAST ABLATION. THE PATIENT EXPERIENCED ASSOCIATED BRADYCARDIA AND A DECREASE IN MEAN ARTERIAL PRESSURE/BLOOD PRESSURE FOR APPROXIMATELY THREE MINUTES. THE ST DEPRESSIONS RETURNED TO BASELINE AND HEART RATE AND PRESSURE STABILIZED WITHOUT ADMINISTRATION OF NITROGLYCERIN. A SMALL PERICARDIAL EFFUSION WAS NOTED BUT WAS NOT CONSIDERED SIGNIFICANT ENOUGH TO CONTR IBUTE TO THE ST DEPRESSIONS. THE PROCEDURE WAS TEMPORARILY INTERRUPTED. THE CASE WAS COMPLETED AND THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Pericardial Effusion

  MAUDE report 24632187 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A STROKE OCCURRED. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 24521503 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, POWER STARTUP ISSUES OCCURRED WHEN THE REMOTE POWERED DOWN WITHOUT CAUSE TWICE, REQUIRING THE PROCEDURE TO BE PAUSED AND THE REMOTE TO BE RESTARTED AND REESTABLISHED AS THE PRIMARY UNIT. DURING DELIVERY OF RADIOFREQUENCY ENERGY, THE ELECTROCARDIOGRAM ON THE ANESTHESIA MONITOR FLATLINED, BUT NORMAL ELECTROCARDIOGRAM RECORDINGS RETURNED AFTER RADIOFREQUENCY ENERGY WAS TURNED OFF. NO OTHER ELECTROCARDIOGRAM EQUIPMENT IN THE ROOM APPEARED AFFECTED BY RADIOFREQUENCY ENERGY. ELECTROCARDIOGRAM MONITORING WAS CONDUCTED THROUGHOUT THE PROCEDURE. THE CASE WAS COMPLETED. THE PATIENT EXPERIENCED PAIN AND SWELLING AROUND THE RIGHT FOREARM NEAR THE PROCEDURAL ARTERIAL LINE. LATER IN THE NIGHT, PAIN AND SWELLING INCREASED. ULTRASOUND WAS PERFORMED AND A HEMATOMA CLOT WAS OBSERVED. THE NEXT DAY, THE PATIENT WAS TAKEN IN FOR A DECOMPRESSIVE FASCIOTOMY ON THE RIGHT HAND. PATIENT WAS HOSPITALIZED UNTIL FEBRUARY 11TH. IT WAS ALSO REPORTED THAT THE PATIENT WAS GOING TO HAVE AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) UPGRADE AND RA LEAD REVISION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Pain; Swelling/ Edema

  MAUDE report 24511432 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, INCREASED PERICARDIAL EFFUSION COMPARED TO BASELINE WAS OBSERVED VIA INTRACARDIAC ECHOCARDIOGRAPHY VISUALIZATION. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, AND PERICARDIOCENTESIS WAS PERFORMED. THE EFFUSION WAS DRAINED, AND AUTO TRANSFUSED BACK TO THE PATIENT, RESULTING IN RESTORED HEMODYNAMIC STABILITY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 24500507 ↗