Sphere-9 CatheterRecalls & reported problems across all models

We found 4 models of Sphere-9 Catheter by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 252 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2025 and Sep 30, 2026 — classified as 8 deaths, 127 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (30 reports).

1 FDA recall record name at least one of these models by its device 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. 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

Sphere-9 Catheter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 11, 2026Open, 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 · names 4 of these models · Recall details · FDA record ↗

Most reported Sphere-9 Catheter problems

Sphere-9 Catheter models

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

• Sphere-9™ Catheter AFR-00001

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall3 deaths147 reports
• Sphere-9™ Catheter AFR-00001

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 recall5 deaths77 reports
• Sphere-9™ Catheter AFR-00001

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  1 recall15 reports
• Sphere-9™ Catheter AFR-00001

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall13 reports

Recent Sphere-9 Catheter adverse event reports

The 15 most recent reports across all models, 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 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that  during a cardiac ablation procedure, during pulsed-field delivery of the first application after creation of a post map, the sphere 9 catheter displayed a hashed appearance with bright electrodes, the green impedance graph was maximized, and the catheter was not displayed properly on the Affera system. After disconnecting and reconnecting the sphere 9 catheter, it was nolonger visualized on the Affera system. Troubleshooting included rebooting the affera system, magnet and then replaced cables, sphere 9 catheter and patches, moved the patient table and imaging equipment, but the issue persisted. The procedure was aborted and not continued using another system. An engineer tested the system the following day and was unable to reproduce the lack-of-visualization issue; the system functioned properly during testing. No patient complications have been reported as a result of this event. 2026-09-25 It was later reported that the case was aborted under general anesthesia.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895801 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block

  MAUDE report 50884581 ↗
• MalfunctionSep 24, 2026Delivered as Unsterile Product

  It was reported that prior to a cardiac ablation procedure when the sphere-9 was taken out of the box, the sterile packaging had a t ear. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882210 ↗
• 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 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure, during left pulmonary vein circumferential isolation, while delivering pulse field energy to the ridge, two applications were performed without noticing that the Sphere 9 catheter had shifted to the left atrial appendage. Afterward, the position was corrected, but on the PostMap, no left atrial appendage potentials could be confirmed. Echocardiogram was planned for one month. The case was completed. No patient complications have been reported as a result of this event.;

  Patient problems: Intraoperative Cardiac Injury

  MAUDE report 50851164 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure, activated clotting time was 371 seconds prior to catheter inserted into the body. Transeptal was performed with another manufacturer guidewire and sheath. Left atrial mapping was performed while the patient was in atrial fibrillation. The patient underwent synchronized cardioversion at 360 joules and rapidly returned to atrial fibrillation and atrial flutter. An antiarrhythmic medication was administered. The heart rate decreased below 50 beats per minute, and pacing was initiated from the coronary sinus catheter. The blood pressure reading was lost. It also noted that the cause for low blood pressure and heart rate is unknown. Pulse could not be felt in the jugular area. Cardiopulmonary resuscitation, Compression was performed. Intracardiac echocardiography (ICE) showed no pericardial effusion, venography showed no femoral vein or artery issues, and laboratory testing was reported as normal. An arterial pressure line was inserted, and pressure stabilized.  The patient was hemodynamically stable at the end of the procedure, remained on a ventilator, and was sent for computed tomography (CT) imaging to rule out stroke. The pr

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 50799475 ↗
• 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 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure a pericardial effusion occurred. Drainage and surgery were performed. The outcome of this case is unknown. No further patient complications have been reported as a result of this event.

  Patient problems: Pericardial Effusion

  MAUDE report 50732295 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure using the Sphere 9 catheter, a pericardial effusion was observed before transseptal access, following Cavo tricuspid isthmus ablation. Following left wide antral circumferential ablation, the patient¿s blood pressure began to fall, and a tamponade/pericardial effusion was reported. Pericardiocentesis was immediately performed, and albumin and fluids were administered. Right wide antral circumferential ablation was performed and the procedure was completed. A pericardial drain was placed, the patient was extubated and transferred to the intensive care unit, and the effusion was stabilized. The patient was admitted for a couple of days, remained stable, and required no further intervention. No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50731305 ↗

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