Sphere-9™ Catheter AFR-00001 (UDI 00763000973506)Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00763000973506), received between Apr 3, 2025 and Sep 25, 2026 — classified as 5 deaths, 42 injuries, 30 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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a repeat cardiac ablation procedure, sinus bradycardia with first-degree atrioventricular block was observed at the end of procedure. It was noted that patient undergone Pulmonary Vein Isolation (PVI) procedure.  It was unknown whether sinus bradycardia with first-degree atrioventricular block were resolved. It was further reported that post-procedure groin bleeding occurred, and the patient was monitored overnight. The following morning, the groin suture was removed, with no further bleeding or hematoma reported. No changes were made to the medication regimen, and no acute events occurred overnight. The groin bleeding resolved, and the patient was discharged. The case outcome is unknown. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Heart Block; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50175935 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a repeat cardiac ablation procedure, sinus bradycardia with first-degree atrioventricular block was observed at the end of procedure. It was noted that patient undergone Pulmonary Vein Isolation (PVI) procedure.  It was unknown whether sinus bradycardia with first-degree atrioventricular block were resolved. It was further reported that post-procedure groin bleeding occurred, and the patient was monitored overnight. The following morning, the groin suture was removed, with no further bleeding or hematoma reported. No changes were made to the medication regimen, and no acute events occurred overnight. The groin bleeding resolved, and the patient was discharged. The case outcome is unknown. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Heart Block; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50175931 ↗
• MalfunctionJun 15, 2026Circuit Failure

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE CATHETER APPEARED KINKED ON THE AFFERA MAPPING SYSTEM DISPLAY JUST PROXIMAL TO THE SHAFT ELECTRODES AFTER IT WAS PREPPED AND ADVANCED THROUGH ANOTHER MANUFACTURER'S SHEATH INTO THE LEFT ATRIUM. FLUOROSCOPY AND INTRACARDIAC ECHOGRAPHY SHOWED THE CATHETER APPEARED STRAIGHT. THE CATHETER WAS UNPLUGGED AND RECONNECTED ON THE CATHETER SIDE AND THE CATHETER INTERFACE UNIT (CIU) SIDE, BUT THE DEFORMED APPEARANCE PERSISTED ON THE MAPPING SYSTEM. THE CATHETER WAS EXCHANGED FOR A NEW ONE, AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505361 ↗
• MalfunctionJun 3, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, WHILE USING RADIOFREQUENCY TO ABLATE ANTERIORLY NEAR THE LEFT ATRIAL APPENDAGE, A STEAM POP OCCURRED. THE PATIENT REMAINED STABLE AND THE PROCEDURE CONTINUED AS NORMAL. 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 25383223 ↗
• MalfunctionJun 3, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE SPHERE 9 CATHETER MALFUNCTIONED AND WAS REMOVED. UPON DIRECT OBSERVATION THERE WAS A SOLID WHITE SUBSTANCE OBSERVED INSIDE THE CATHETER TIP. THE SUBSTANCE WAS CONFIRMED BY PATHOLOGY TO BE FIBRIN. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED TRANSIENT ARM WEAKNESS AND WAS NOTED THAT IT MAY HAVE BEEN A TIA (TRANSIENT ISCHEMIC ATTACK), HOWEVER COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS NEGATIVE AND THERE WERE NO RESIDUAL NEUROLOGICAL ISSUES. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 25382761 ↗
• MalfunctionJun 1, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND TO BE IN THE CATHETER TIP UPON REMOVAL OF THE CATHETER AFTER A CARDIAC ABLATION PROCEDURE. THE PATIENT WAS IN SINUS RHYTHM UPON ARRIVAL TO THE PROCEDURE. THE PATIENT SUCCESSFULLY HAD A PULMONARY VEIN ISOLATION (PVI), WIDE AREA CIRCUMFERENTIAL ABLATION (WACA), CAVOTRICUSPID ISTHMUS (CTI), MITRAL, ROOF LINE, INFERIOR LINE, POSTERIOR WALL ABLATIONS DONE, AS WELL AS A TOUCH UP TO A CTI LINE DONE A FEW MONTHS PRIOR. IT WAS NOTED THAT THERE WAS NO MATERIAL IN THE CATHETER TIP WHENTHE CATHETER WAS REMOVED FROM THE RIGHT ATRIUM FOR TRANSEPTAL PROCEDURE, SO THE CATHETER WAS PREPPED A SECOND TIME PRIOR TO INSERTION BACK INTO THE PATIENT AND ADVANCED INTO THE LEFT ATRIUM FOR MAPPING, FOLLOWED BY THE RIGHT ATRIUM FOR MAPPING. NO ABLATIONS WERE DONE WHILE THE CATHETER WAS IN THE BODY FOR THE SECOND TIME. IT IS UNKNOWN WHERE THE MATERIAL ORIGINATED FROM, BUT IT WAS REPORTED THAT THE CATHETER HAD BEEN IN THE LEFT ATRIUM, RIGHT ATRIUM, INFERIOR VENA CAVA, AND FEMORAL VEIN. THE PHYSICIAN THOUGHT HE REMOVED THE CATHETER WHILE EXPOSED OUTSIDE OF THE SHEATH, AS HE DID NOT REMEMBER WITHDRAWING THE CATHETER INTO THE SHEATH, AND THEN REMOVING THE SHEATH. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350321 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST CARDIAC ABLATION PROCEDURE, THE SPHERE 9 CATHETER WAS REMOVED FROM THE PATIENT. ST SEGMENT ELEVATION WAS OBSERVED IN THE PATIENT APPROXIMATELY 20 MINUTES AFTER THE LAST ABLATION AND 7 MINUTES AFTER PROTAMINE WAS GIVEN. NITROGLYCERIN WAS ADMINISTERED AND THE ST SEGMENT ELEVATION IMPROVED. THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA, REPORTED TO HAVE NO CHEST PAIN AND WAS TAKEN TO RECOVERY. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25332125 ↗
• MalfunctionMay 26, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER REMOVAL OF THE SPHERE 9 CATHETER, IT WAS OBSERVED THAT WHITE TO LIGHT RED, OPAQUE TISSUE WAS STUCK TO THE LATTICE OF THE SPHERE. 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 25281837 ↗
• DeathMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE DAYS FOLLOWING A CARDIAC ABLATION PROCEDURE, THE PATIENT WENT TO A FOLLOW-UP VISIT AND WAS "DOING WELL." AFTER THE APPOINTMENT, THE PATIENT COLLAPSED AND COULD NOT BE RESUSCITATED. THE PATIENT DIED. IT WAS NOTED THAT THE PATIENT HAD A "SICK HEART," AND THE DEATH WAS ATTRIBUTED TO THE PREEXISTING CARDIOMYOPATHY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25164383 ↗
• MalfunctionApr 28, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, SOFTWARE LAG WAS OBSERVED THROUGHOUT THE CASE, WITH THE GATED GRAPH FREEZING FOR A FEW SECONDS AFTER INITIATING ABLATION AND THE CONNECT LINE TAKING ABOUT A MINUTE TO CHANGE COLOR IN SOME LESION LOCATIONS DESPITE NO ADDITIONAL LESIONS OR REGROUPING. WHILE ABLATING THE ROOF LINE, THE D1 MINI BEGAN TO MALFUNCTION, CAUSING TEMPERATURE SPIKES AND PREVENTING PULSED FIELD (PF) ENERGY DELIVERY. TROUBLESHOOTING INCLUDED UNPLUGGING AND REPLUGGING THE CABLE FROM THE CATHETER, WHICH DID NOT RESOLVE THE ERROR. THE CATHETER WAS REPLACED, AND PF ENERGY DELIVERY WAS SUCCESSFUL WITH THE NEW DEVICE, THOUGH IT WAS LATER REPORTED THAT THE SOFTWARE ISSUES DID NOT RESOLVE 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 25016413 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A COMPLETE HEART BLOCK WAS OBSERVED WHILE FINISHING AN ANTERIOR LEFT ATRIUM MITRAL FLUTTER LINE. THE PROCEDURE, WAS ABORTED, AND THE WAS IMPLANTED WITH A PERMANENT LEADLESS PACEMAKER AFTER A WAITING PERIOD WHERE NORMAL CONDUCTION HADN'T RETURNED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block

  MAUDE report 24887586 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. THE PATIENT RECEIVED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE.

  Patient problems: Heart Block

  MAUDE report 24866703 ↗
• MalfunctionApr 13, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE CATHETER WAS NOT SENSING CORRECTLY, AND AN AUDIBLE POP WAS HEARD. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. 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 24866510 ↗
• DeathApr 8, 2026Electromagnetic Interference; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, WHILE FINISHING ABLATION IN THE LEFT ATRIUM, THE PATIENT, WHO WAS NOTED TO HAVE AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), BEGAN HAVING RUNS OF VENTRICULAR TACHYCARDIA (VT). THE PATIENT WAS PACED OUT OF VT, BUT CONTINUED TO GO BACK INTO VT EITHER SPONTANEOUSLY OR JUST AFTER A PULSED-FIELD LESION, AND THE CASE CONTINUED IN THIS MANNER UNTIL POSTERIOR WALL ISOLATION WAS COMPLETED. THE RUNS OF VT WORSENED AFTER THE ABLATION WAS COMPLETED, AND LEFT VENTRICULAR MAPPING WAS INITIATED IN AN ATTEMPT TO IDENTIFY A TRIGGER. DURING INITIAL MAPPING, THE PATIENT DECOMPENSATED QUICKLY AND AGAIN WENT INTO VT. THE PATIENT WENT INTO CARDIAC ARREST AND DIED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24820177 ↗
• MalfunctionApr 8, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING USE OF THE SPHERE CATHETER FOR CTI RADIOFREQUENCY ABLATION, CHAR FORMATION ON THE CATHETER TIP WAS OBSER VED. THE CATHETER WAS REPLACED WHICH RESOLVED THE 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 24816448 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  It was further reported that the patient was discharged in stable condition the following day.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Heart Block

  MAUDE report 24776113 ↗
• MalfunctionApr 2, 2026Off-Label Use

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, AN EXPIRED CATHETER EXPERIENCED RESISTANCE WHEN TRYING TO PASS THROUGH ANOTHER MANUFACTURER'S INTRODUCER, AND THE INTRODUCER BECAME KINKED. THE CATHETER AND INTRODUCER WERE RE-PREPPED, AND THE ISSUE WAS RESOLVED. 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 24764565 ↗
• InjuryMar 31, 2026Electromagnetic Compatibility Problem

  IT WAS LATER REPORTED THAT THE SHOCK FUNCTION OF THE PATIENT'S IMPLANTED CARDIAC DEVICE WAS TURNED OFF FOR THE PROCEDURE, AND THERE WAS NO ABLATION DELIVERED NEAR THE PATIENT'S IMPLANTABLE CARDIAC DEVICE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745595 ↗
• MalfunctionMar 31, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION ON THE CAVOTRICUSPID ISTHMUS (CTI) NEAR THE INFERIOR VENA CAVA (IVC), A STEAM POP OCCURRED DURING ABLATION AT LESION 102. 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 24743501 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, VENTRICULAR FIBRILLATION OCCURRED AFTER ABLATION AT THE CAVOTRICUSPID ISTHMUS (CTI) WHILE AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS PRESENT. THE EVENT LED TO AN EXTENDED HOSPITALIZATION WITH AN OVERNIGHT STAY. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24734666 ↗
• MalfunctionMar 30, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE CASE CONTINUED AS NORMAL. THE CASE WAS COMPLETED. UPON REMOVAL OF THE SHEATH AND CATHETER FROM THE BODY AS ONE UNIT, TISSUE WAS OBSERVED ON THE CATHETER LATTICE, AND THE CATHETER WAS FLUSHED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734518 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT REMAINED HOSPITALIZED FOR APPROXIMATELY ONE WEEK AND THEN WENT TO REHABILITATION. THE PATIENT WAS DISCHARGED FROM REHABILITATION APPROXIMATELY ONE WEEK AND A HALF LATER.

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Tachycardia; Unspecified Heart Problem

  MAUDE report 24731391 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT A SCAN AFTER THE CASE. THE SYMPTOMS LATER RESOLVED AND THE PATIENT WAS DISCHARGED THE NEXT DAY.

  Patient problems: Blurred Vision; Stroke/CVA

  MAUDE report 24729937 ↗
• MalfunctionMar 30, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, AN AUDIBLE STEAM POP WAS HEARD DURING A RADIOFREQUENCY LESION ON THE CAVOTRICUSPID ISTHMUS (CTI). ARTERIAL LINE MONITORING WAS IN PLACE AND NO PRESSURE FLUCTUATION WAS REPORTED. THE PATIENT WAS MONITORED FOR EFFUSION ON INTRACARDIAC ECHOCARDIOGRAPHY AND NO EFFUSION WAS OBSERVED. 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 24728838 ↗