Sphere-9™ AFR-00001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000871741), received between Dec 4, 2024 and May 5, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 16, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CATHETER TEMPERATURE SENSOR FAULT OCCURRED, WITH ONE OF THE TEMPERATURE SENSORS BEING OUT OF RANGE. THIS LED TO A PULSED FIELD DELIVERY ERROR AND AN ERROR MESSAGE BEING DISPLAYED, TEMPORARILY INTERRUPTING THE PROCEDURE. IT WAS NOTED THAT THE TRANSEPTAL APPROACH WAS CHALLENGING DUE TO AN ANEURYSMAL SEPTUM, AND THE CATHETER WAS EXCHANGED THROUGH ANOTHER MANUFACTURER'S SHEATH SEVERAL TIMES. CONNECTIONS WERE CHECKED, AND ULTIMATELY, A NEW CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER ISSUES WERE EXPERIENCED AFTER 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 21959877 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, VENTRICULAR FIBRILLATION OCCURRED ON THE FIRST AND SECOND RADIOFREQUENCY (RF) LESIONS OF THE CAVOTRICUSPID ISTHMUS (CTI) LINE, NECESSITATING DEFIBRILLATION EACH TIME. THE PROCEDURE WAS SWITCHED TO PULSED FIELD (PF) ABLATION FOR THE REMAINING LESIONS ON THE CTI LINE, WHICH PROCEEDED WITHOUT FURTHER ISSUES. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 21283668 ↗
• MalfunctionJan 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT MATERIAL WAS FOUND IN THE ABLATION CATHETER POST-PROCEDURE. THE ISSUE OCCURRED DURING REMOVAL OF THE DEVICE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT, AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230667 ↗
• MalfunctionJan 6, 2025

  CHAR WAS PRESENT ON THE TIP OF THE CATHETER ON REMOVAL FROM BODY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078677 ↗
• MalfunctionJan 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE CATHETER WAS REMOVED FROM THE BODY TO CLEAR A BUBBLE ALERT, AND UPON REMOVAL, BLOOD MATTER WAS NOTED ON THE LATTICE TIP OF THE CATHETER. IT WAS NOT POSSIBLE TO REMOVE THE BLOOD MATTER BY FLUSHING THROUGH THE PUMP OR BY MANUALLY CLEANING THE LATTICE. THE CATHETER WAS REPLACED, AND THE CASE WAS COMPLETED. THE ACTIVATED CLOTTING TIME (ACT) WAS ABOVE 350 SECONDS FOR THE DURATION OF THE ENTIRE CASE AND BEFORE THE CATHETER ENTERED THE BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072072 ↗
• MalfunctionJan 3, 2025

  ABLATION CATHETER NOT RECOGNIZED WHEN CONNECTED TO AFFERA MAPPING SYSTEM. REPLACED WITH RESOLUTION OF ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066164 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS OBSERVED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AFTER THE CATHETER WAS WITHDRAWN FROM THE LEFT ATRIUM AND INTO THE RIGHT ATRIUM. A PERICARDIAL TAP WAS PERFORMED TO REMOVE BLOOD FROM THE PERICARDIAL SPACE. A CARDIOTHORACIC SURGEON WAS CONSULTED, AND A MEDIAN STERNOTOMY WAS PERFORMED. IT WAS FURTHER REPORTED THAT UPON DIRECT VISUAL INSPECTION OF THE HEART, THERE WERE NO PERFORATIONS NOTED AND NO ACTIVE BLEEDING. THE PATIENT REGAINED HEMODYNAMIC STABILITY AND REMAINED STABLE. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT'S HOSPITALIZATION WAS EXTENDED FOR AN UNKNOWN DURATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20847740 ↗