HexaPulse™ PF Generator AFR-00008 (UDI 00763000871925)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000871925), received between Sep 5, 2025 and Sep 25, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P240013); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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 cardiac ablation procedure, issue with return 1 port was observed. It was noted that ¿Return 1 contact-quality-invalid error¿ message was displayed. Grounding patches were replaced without resolve. Adapter and gen link cable were replaced without resolution. Additionally, the system was rebooted multiple times, and the cable was reseated which did not resolve the i ssue. The procedure was aborted and was not continued with another system. Service was requested. Technical services initially requested replacement of the return electrode adapter. Pulsed field generator (PFG) issue was verified during servicing, and it was determined that the issue was related to pulsed field generator (PFG) only. Patient grounding block sheathing with wires. High impedance was confirmed on port 1 of the pulsed field generator (PFG). PFG Assembly was replaced. The console was serviced as appropriate. No further patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900785 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT ADDITIONAL ERRORS WERE RECEIVED INDICATING THE RETURN 1 CONTACT QUALITY WAS INVALID AND THAT THERE WAS A TEMPERATURE ACQUISITION CIRCUIT FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497797 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO A CARDIAC ABLATION PROCEDURE, THE FRONT OF THE PULSE FIELD GENERATOR (PFG) WAS DAMAGED. THE ABLATION RETURN LINK CABLE WAS REPORTED TO BE "RIPPED" OUT OF THE FRONT OF THE SYSTEM. THE PROCEDURE WAS UNABLE TO START AND THE PATIENT WAS ALREADY UNDER GENERAL ANESTHESIA WHEN THE CASE WAS ABORTED. TECHNICAL SERVICES RECOMMENDED SERVICE FOR REPLACEMENT OF THE PFG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24347972 ↗
• InjuryDec 17, 2025Communication or Transmission Problem; Computer Operating System Problem; Communication or Transmission Problem; Computer Operating System Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A PULSE FIELD GENERATOR(PFG)/CATHETER INTERFACE UNIT (CIU) ERROR OCCURRED, AND A CIU FIRMWARE VERSION MISMATCH. THE COMMUNICATION CABLES WERE RECONNECTED WITHOUT RESOLVE. THE ELECTROGRAM SIGNALS DROPPED WHILE RESPIRATION CONTINUED. TO RESOLVE THE ISSUE, THE CASE WAS EXITED AND RE-ENTERED ALONG WITH REBOOTING AND RESULTED IN NOT BEING ABLE TO PACE. THE CATHETER TEMPERATURE SENSOR FAULT LED TO THE CATHETER BEING REPLACED TWO TIMES, WITH THE ERROR NOT CONSISTENTLY ASSOCIATED WITH ONE ELECTRODE. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT RECEIVED TREATMENT FOR PULMONARY VEIN ISOLATION (PVI) AND DID NOT GET PRE-EMPTIVE CAVOTRICUSPID ISTHMUS (CTI) ABLATION FOR TYPICAL FLUTTER. SERVICE RECOMMENDED REPLACEMENT OF THE PFG/CIU. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832228 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT PULSED FIELD ABLATIONS WERE BEING UTILIZED AROUND THE LEFT PULMONARY VEINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017151 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE CASE WAS ABORTED AFTER TRANSSEPTAL DEVICE USAGE DUE TO CATHETER TEMPERATURE SENSOR FAULT. THE PROCEDURE WAS UNABLE TO DELIVER ENERGY BECAUSE OF A PULSE FIELD GENERATOR (PFG) FAULT. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND NO ABLATION WAS POSSIBLE DURING THE ENTIRE PROCEDURE. TROUBLESHOOTING STEPS INCLUDED CHANGING ELECTRICAL CABLES, CHANGING THE SPHERE 9 CATHETER, REBOOTING THE SYSTEM, REDOING THE PREPARATION SEQUENCE, MAPPING, PACING, CREATING A NEW PROCEDURE, AND CONTACTING TECHNICAL SUPPORT. A NEW PFG WAS INSTALLED THE FOLLOWING DAY AND NO FURTHER ISSUES WERE OBSERVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975297 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P240013. One submission often covers many models, so check the product and lot details in each record.

• Z-1948-2026 · Mar 11, 2026 · Open, Classified
  Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.