Sphere-9™ Catheter AFR-00001 (UDI 00199150003709)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00199150003709), received between Jul 29, 2026 and Sep 24, 2026 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  It was reported that during a cardiac ablation procedure mapping would quickly come off collection. This occurred for the first 2-3 minutes and resolved on its own. On the third radiofrequency lesion, a steam pop was "felt and heard". The case continued as no issue arose. A temperature sensor fault occurred and remained while mapping the left atrium. The catheter was replaced which resolved the issue. 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 50716984 ↗
• MalfunctionSep 10, 2026Device Contamination with Chemical or Other Material

  It was reported that upon removal of the sphere-9 catheter during a cardiac ablation procedure, a dark substance was noted on the tip of the sphere-9 cage. There were no other issues or complications observed. 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 50716662 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure treating ventricular tachycardia, permanent type 3/complete heart block occurred during radiofrequency ablation. The patient arrived in sinus rhythm and was ablated during ventricular tachycardia and sinus rhythm. Pulsed field ablation and radiofrequency ablation lesions were created in the ventricle, including a left ventricular location. Atrioventricular dissociation was observed after ablation. Intracardiac echocardiography was used to confirm the target location and proximity to the conduction system before ablation; the original location was not very close to the conduction system, but the catheter moved closer during the procedure and the physician was notified. No energy delivery issues or medications that could contribute to heart block were reported. A leadless implantable pulse generator pacemaker was implanted as a permanent intervention for the heart block, adding the pacemaker implant to the procedure. No catheter issue was reported. The outcome of this case is unknown. No further patient complications have been reported as a result of this event.

  Patient problems: Heart Block

  MAUDE report 50672060 ↗
• MalfunctionSep 8, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671212 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a cardiac ablation procedure, before the catheter was inserted into the body, a temperature sensor fault issue was observed. The wired component was replaced; however, the fault sensor issue persisted until the catheter was replaced. Midway through the procedure, a bubble detection alarm activated. The catheter was removed, the line was checked, and the sheath was re-prepped. A block on the right end of the pump was observed to have slipped out, and the procedure subsequently continued normally. Near the end of the procedure, the heparinized saline bag was low and required replacement. While the anterior line was assessed for block, the bubble detection alarm activated again. The system was removed and re-prepped, and the heparinized saline bag was replaced. The physician performed final pacing before catheter removal. The case was completed. On the night following the procedure, the patient experienced a stroke and was subsequently reported as stable and recovering. No further patient complications have been reported as a result of this event.

  Patient problems: Stroke/CVA

  MAUDE report 50351436 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during cardiac ablation procedure, the patient had a non-Medtronic device that had been implanted for approximately four years. The physician attempted to deliver a pulsed field ablation lesion near or on top of the device, and the temperature spiked rapidly during ablation. Two additional lesions were delivered near the area without further drastic temperature changes. Intracardiac echocardiography imaging of the left atrium identified clot or endothelial tissue in the area of the device. A suction device was used to remove the tissue. The procedure was aborted and the patient was under general anesthesia. No further patient complications have been reported as a result of this event.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50161607 ↗
• MalfunctionAug 5, 2026Use of Device Problem; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143636 ↗
• MalfunctionJul 29, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067608 ↗