HexaFlow™ Irrigation Pump AFR-00005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000871895), received between Jul 8, 2025 and Nov 19, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Alarm System” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, A PUMP EXHIBITED HARDWARE ERROR 074 AND REPEATEDLY REBOOTED, RESULTING IN THE ABORTION OF THE PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS CARDIOVERTED AND DID NOT RECEIVE ALTERNATE THERAPY FROM ANOTHER PRODUCT. A SERVICE VISIT OCCURRED ON A LATER DATE AND THE PUMP WAS REPLACED. THE PUMP WAS TESTED TO VERIFY FUNCTIONALITY AND AN EXTENDED SELF TEST WAS COMPLETED. NO ADVERSE PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598785 ↗
• InjuryJul 8, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE IRRIGATION PUMP'S TOUCHSCREEN FROZE. REBOOTS DID NOT RESOLVE THE ISSUE. ABLATIONS IN THE LEFT ATRIUM WERE COMPLETED AND THE CAVOTRICUSPID ISTHMUS (CTI) LINE IN THE RIGHT ATRIUM WAS NOT COMPLETED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. SERVICE WAS PERFORMED AND THE IRRIGATION PUMP WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439863 ↗

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.