Sphere-9™ Catheter AFR-00001 (UDI 00763000993269)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000993269), received between Jun 5, 2026 and Sep 30, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Contamination with Chemical or Other Material

  It was reported that during a cardiac ablation procedure, on completion of a cavotricuspid isthmus ablation, a bubble detection error occurred after the water bag was switched. The Sphere 9 catheter was removed for re-preparation, and darker material was observed on/in the lattice tip. The physician manipulated the darker material, and the electrodes were damaged. The procedure was continued with competitor system. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943642 ↗
• MalfunctionSep 25, 2026Device Contamination with Chemical or Other Material; No Apparent Adverse Event

  It was reported that during a cardiac ablation procedure, a steam pop was observed in intracardiac echocardiography (ICE) . No audible sound, temperature change, or impedance change was observed. The catheter was removed and inspected; no char was observed but a 1 mm piece of cardiac tissue was present in 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 50899877 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block

  MAUDE report 50884581 ↗
• MalfunctionSep 23, 2026Device Contamination with Chemical or Other Material

  It was reported that during a cardiac ablation procedure for atrial fibrillation and atypical atrial flutter, ablation included the left and right pulmonary veins, posterior wall, and an anterior mitral line, with 108 pulsed field lesions and 7 radiofrequency lesions. One pulsed field lesion temperature was above 46 °C, and one radiofrequency lesion temperature was above 74 °C. A therapeutic activated clotting time of 350 was not achieved despite additional heparin boluses. Activated clotting time values were 264 at insertion, 547, 282, 453, and 282 during follow-up, and 282 at the end of the procedure. During removal of the catheter, congealed gel-like material was observed adhered to the catheter tip. The irregularly shaped pink and yellow material originated from the left atrium. 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 50871748 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure for treatment of atrial fibrillation with the Sphere 9 catheter, pulsed field ablation and approximately eight radiofrequency ablation lesions were performed. Pulmonary vein isolation, posterior wall ablation, and an anterior mitral line were created. The patient converted from atrial fibrillation to sinus rhythm during pulmonary vein isolation, and atrial flutter was induced. Complete type 3 heart block occurred during radiofrequency ablation on the anterior wall at the anteroinferior side of the mitral valve. The patient developed an underlying junctional rhythm. The ablation target location and proximity to the conduction system were not confirmed with imaging before ablation. Dopamine was administered, and a temporary pacing wire was placed. Cardiac conduction recovered overnight. The procedure was aborted. No energy-delivery or electrogram issues were observed, and no issues were identified with the Sphere 9 catheter. The patient was doing well, and was being discharged.

  Patient problems: Heart Block

  MAUDE report 50867370 ↗
• MalfunctionSep 22, 2026Entrapment of Device

  It was reported that during a cardiac ablation procedure, during right atrial mapping, the catheter became stuck while crossing the tricuspid valve. The physician attempted to maneuver and disengage the catheter for several minutes without success, and it was suspected that it was caught in a papillary muscle. The procedure was temporarily interrupted. The catheter handle was cut off to exchange the short sheath for a longer sheath, which was used to facilitate catheter removal. Intracardiac echocardiography performed after removal showed that the tricuspid valve appeared to function normally, and no obvious tissue was observed on the catheter lattice. Access was regained, and the procedure continued with a new catheter without further incident. 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 50852815 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following a cardiac ablation procedure, the patient arrived in atrial fibrillation. Atrium ablation lesions were created. Transeptal access was utilized during the procedure. The patient was not on oral anticoagulation prior to procedure. Continuous irrigation was maintained on both catheter and sheath. Heparinized saline was used to flush the sheath. Imaging was not performed prior to beginning of the procedure to rule out thrombus. The patient showed loss of strength in their right hand the next day after procedure. A Computerized Tomography (CT) scan was performed the day after the procedure but results were clear. An Magnetic Resonance Imaging (MRI) was then performed 2 days after the procedure and showed an acute embolic event in the patient's posterior frontal lobe. No intervention was required to treat the issue. The case was completed. No further patient complications have been r eported as a result of this event.

  Patient problems: Embolism/Embolus; Muscle Weakness/Atrophy

  MAUDE report 50786624 ↗
• MalfunctionSep 16, 2026No Apparent Adverse Event

  It was reported that during a cardiac ablation procedure a steam pop was felt and observed on intracardiac echocardiography. No effusion had occurred. 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 50786599 ↗
• MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material

  It was reported that during a cardiac ablation procedure, upon opening the package of the catheter, a white substance was observed on the catheter handle. The catheter was replaced and the procedure continued. 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 50752160 ↗
• MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690954 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that post operatively to a cardiac ablation procedure a pericardial effusion occurred. A pericardiocentesis was performed which resolved the issue. No further patient complications have been reported as a result of this event.

  Patient problems: Pericardial Effusion

  MAUDE report 50689814 ↗
• MalfunctionSep 8, 2026No Apparent Adverse Event

  It was reported that during a cardiac ablation procedure, an audible steam pop was heard during the second-to-last radiofrequency lesion on the cavotricuspid isthmus line near the inferior vena cava. The procedure was temporarily interrupted. The physician continued the procedure and delivered one additional radiofrequency lesion on the cavotricuspid isthmus. Pulmonary vein isolation and posterior wall isolation were successfully performed using pulsed field ablation. A mitral isthmus line was treated using radiofrequency ablation and pulsed field ablation, and a cavotricuspid isthmus line was treated using radiofrequency ablation only. 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 50663287 ↗
• MalfunctionSep 1, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543703 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure, a temperature sensor error occurred. The catheter was replaced which resolved the issue. The case was completed. It was also reported that a few hours after the procedure, the patient experienced a stroke. Computed tomography imaging was performed to confirm or diagnose the stroke. The patient had right-sided weakness and facial droop that did not fully resolve and was treated with thrombolytics. No further patient complications have been reported as a result of this event.

  Patient problems: Stroke/CVA

  MAUDE report 50159302 ↗
• MalfunctionJun 5, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE PREPARATION FOR A CARDIAC ABLATION PROCEDURE, A WHITE POWDERY SUBSTANCE WAS OBSERVED ON THE RESISTANCE KNOB OF THE HANDLE WHEN THE STERILE PACKAGING OF THE SPHERE-9 CATHETER WAS OPENED. THE CATHETER WAS REMOVED FROM THE STERILE FIELD AND REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404113 ↗