Affera™ Mapping System AFR-00003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000871956), received between Jun 27, 2025 and Feb 16, 2026 — classified as 5 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A DISPLAY FAILURE OCCURRED ON THE SECONDARY MONITOR, RESULTING IN AN UNSUPPORTED SPEED/DUPLEX CONFIGURATION ERROR AND INABILITY TO DISPLAY ANYTHING IN THE CONTROL ROOM. TROUBLESHOOTING STEPS INCLUDED UNPLUGGING EVERY CONNECTION, REBOOTING, RELOCATING THE WORKSTATION TO A CONFERENCE ROOM WHERE IT FUNCTIONED PROPERLY, AND SWITCHING THE RESOLUTION TO RESOLVE THE ISSUE, WHICH WAS THEN CONFIRMED IN THE LAB. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349651 ↗
• InjurySep 10, 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, A LOCATION REFERENCE ADAPTER WAS PHYSICALLY DAMAGED. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. TECHNICAL SERVICES RECOMMENDED CABLE REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013164 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE, THE LOCATION REFERENCE ADAPTER WAS PHYSICALLY DAMAGED WHEN IT WAS PULLED OUT OF THE PLUG. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER ANESTHESIA. TECHNICAL SERVICES RECOMMENDED REPLACEMENT OF THE LOCATION REFERENCE ADAPTER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727492 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE CASE WAS COMPLETED WITH ANOTHER MANUFACTURER'S SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541620 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 'CIU OFFLINE' NOTIFICATION OCCURRED WITH THE CATHETER INTERFACE UNIT (CIU) PRIOR TO USE DURING SETUP FOR A PROCEDURE, RESULTING IN NO LIGHTS ON THE CIU AND THE PROCEDURE BEING ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA BEFORE ELECTROPHYSIOLOGY ACCESS WAS OBTAINED. THE CASE WAS CANCELLED. MULTIPLE TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING REBOOTING THE SYSTEM MULTIPLE TIMES, SWAPPING FIBER AND ETHERNET CABLES AND PORTS, RUNNING AN ETHERNET CABLE FROM THE CIU TO THE WORKSTATION, CHANGING PRESETS ON THE RADIOFREQUENCY (RF) GENERATOR TO CHECK COMMUNICATION, AND CONDUCTING ELECTRICAL SAFETY AND FIELD SERVICE TESTS ON THE SYSTEM. TECHNICAL SERVICES RECOMMENDED REPLACEMENT OF THE CIU. THE CATHETER INTERFACE UNIT WAS REPLACED, AND THE SYSTEM WAS INSTALLED AND TESTED, WITH ELECTRICAL SAFETY AND FIELD SERVICE TESTS PERFORMED. NO UNCORRECTABLE FAULTS WERE NOTED, AND THE SYSTEM WAS DEEMED READY FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346632 ↗