rezum Generator G2200-003HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729986867), received between Jul 28, 2025 and Nov 14, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO THE WATER VAPOR THERAPY PROCEDURE, THE DELIVERY DEVICE COULD NOT WORK BECAUSE THE GENERATOR DISPLAYED ERROR 275 SYRINGE WATER FILL ERROR. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554883 ↗
• MalfunctionNov 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO THE WATER VAPOR THERAPY PROCEDURE, THE DELIVERY DEVICE COULD NOT WORK BECAUSE THE GENERATOR DISPLAYED ERROR 275 SYRINGE WATER FILL ERROR. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554636 ↗
• MalfunctionJul 28, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT, DURING A WATER VAPOR THERAPY PROCEDURE, ERROR 495 (RF POWER SUPPLY SELF-TEST ERROR) WAS DISPLAYED. IT WAS UNCLEAR WHETHER THE ERROR WAS CAUSED BY A PROBLEM WITH THE GENERATOR OR THE DELIVERY DEVICE. THE DELIVERY DEVICE WAS UNPACKED AND CONNECTED TO THE GENERATOR, BUT THE ISSUE PERSISTED, SO THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631671 ↗