rezum Generator G2200-003RRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729986843), received between Dec 6, 2019 and Jun 30, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHYSICIAN EXPERIENCED ISSUES WITH THE GENERATOR DURING FOUR PROCEDURES. IT REPEATEDLY DISPLAYED ALERT MESSAGES AND THE SCREEN WENT BLANK. THREE BENIGN PROSTATIC HYPERPLASIA CASES WERE COMPLETED, BUT PROCEDURE TIMES WERE PROLONGED DUE TO THE DEVICE MALFUNCTION. THE FOURTH CASE WAS ABORTED. THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673548 ↗
• MalfunctionJun 29, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE, THE DELIVERY DEVICE DID NOT PRODUCE STEAM WHEN CONNECTED TO THE GENERATOR. IT WAS NOTED THAT THE GENERATOR WAS RESTARTED AND THE CONNECTION WAS CHECKED; HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661388 ↗
• MalfunctionDec 15, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PROCEDURE, A LOW-TEMPERATURE ERROR PROMPTED, AND NO STEAM WAS EMITTED. THE ISSUE PERSISTED EVEN AFTER RESTARTING DEVICE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. ADDITIONAL INFORMATION NOTED THAT THE PATIENT WAS TEMPORARILY DISCHARGED AND IS SCHEDULED FOR A REOPERATION ON A DIFFERENT DATE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804982 ↗
• MalfunctionJan 22, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THERE WAS AN ERROR MESSAGE DISPLAYED. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE ABORTED DUE TO THIS MALFUNCTION. 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 21213953 ↗
• MalfunctionMar 26, 2024Power Problem; Power Problem

  IT WAS REPORTED THAT PRIOR TO A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, ERROR 495 (RF POWER SUPPLY SELF-TEST ERROR) WAS DISPLAYED ON THE GENERATOR. THE DEVICE WAS RESTARTED, AND THREE DELIVERY DEVICES WERE USED IN TOTAL, BUT THE ERROR PERSISTED. DUE TO THIS, THE PROCEDURE WAS RESCHEDULED. 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 18983858 ↗
• MalfunctionFeb 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, AFTER CONNECTING THE REZUM GENERATOR, THE PHYSICIAN WAS DOING THE PRIMING STEP AND THEN TRIED COUPLE OF TREATMENTS OUTSIDE THE PATIENT TO MAKE SURE THE VAPOR AND TEMPERATURE WAS WORKING PROPERLY, BUT THE DEVICE NEVER REACHED THE HEAT TEMPERATURE TO CONTINUE WITH PROCEDURE. THE PHYSICIAN TRIED WITH TWO (2) DIFFERENT DELIVERY DEVICES AND MADE MORE THAN 5 TREATMENTS OUTSIDE OF THE PATIENT, BUT THE PROBLEM PERSISTS. THE PHYSICIAN CANCELLED THE PROCEDURE, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655905 ↗
• MalfunctionJan 31, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE, DURING PRIMING, THE PHYSICIAN TRIED A COUPLE TREATMENTS OUTSIDE OF THE PATIENT TO ENSURE THE VAPOR AND TEMPERATURE WERE WORKING PROPERLY, BUT THE DEVICE NEVER REACHED THE DESIRED HEAT TEMPERATURE. THE PHYSICIAN TRIED WITH TWO OTHER DELIVERY DEVICES, BUT THE PROBLEM PERSISTED. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH OR UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615663 ↗
• MalfunctionAug 14, 2023Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DELIVERY DEVICE SCREEN FLICKERS DURING USE. THERE WAS UNABLE TO SEE ANYTHING ON THE DISPLAY, THEREFORE THIS PROCEDURE WAS NOT COMPLETED. THE EVENT OCCURRED OUTSIDE THE PATIENT, NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540795 ↗
• MalfunctionJun 26, 2023Impedance Problem; Material Integrity Problem; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING PREPARATION FOR A BENIGN PROSTATIC HYPERPLASIA PROCEDURE, THE GENERATOR WAS NOT OPERATING AS INTENDED DURING PRIMING AND ERROR 218 WAS DISPLAYED. TROUBLESHOOTING, INCLUDING REPLACEMENT OF THE DELIVERY DEVICES, WAS ATTEMPTED TO NO AVAIL. A GENERATOR ISSUE WAS CONFIRMED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17201652 ↗
• MalfunctionJun 2, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE, THE DEVICE DISPLAYED ERROR MESSAGES DURING THE PRIMING STATE. THE PROCEDURE COULD NOT BE COMPLETE DUE TO THESE ERRORS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17045701 ↗
• MalfunctionDec 20, 2022Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNIT IS CONSISTENTLY GIVING ERROR MESSAGES (PRIMING CYCLE WOULD NOT COMPLETE) DURING THE DEVICE PRIME STAGE. PROCEDURE WAS NOT PERFORMED, AND PATIENT WAS ALREADY SEDATED UNDER GENERAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018089 ↗
• MalfunctionNov 17, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING PREPARATION FOR A WATER VAPOR THERAPY PROCEDURE, ERROR MESSAGES KEPT OCCURRING DURING THE PRIMING STAGE. TROUBLESHOOTING STEPS WERE PERFORMED TO NO AVAIL. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821185 ↗
• MalfunctionJun 7, 2022Adverse Event Without Identified Device or Use Problem; Pressure Problem; Adverse Event Without Identified Device or Use Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY, THE GENERATOR DISPLAYED ERROR CODE 465 (WATER PRESSURE SELF TEST ERROR). THE STAFF WAS UNABLE TO CLEAR THE ERROR; THEREFORE, THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626305 ↗
• MalfunctionAug 5, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A WATER VAPOR THERAPY PROCEDURE, GENERATOR ERROR CODES 341: RF POWER TOLERANCE LIMIT EXCEEDED AND 400: RF POWER SUPPLY ERROR OCCURRED DURING THE INITIAL PRIME OF THE DELIVERY DEVICE. THE PATIENT WAS PRESENT AND UNDER GENERAL ANESTHESIA AT THE TIME THE ERROR CODES OCCURRED. THE PROCEDURE WAS CANCELLED DUE TO THE ISSUES WITH THE GENERATOR. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285264 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DURING THE CONVECTIVE RADIOFREQUENCY WATER VAPOR THERMAL THERAPY PROCEDURE THE GENERATOR RECEIVED THE ERROR MESSAGE, "40000: GENERATOR ERROR". THE CASE WAS CANCELLED DUE TO THIS EVENT WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9432320 ↗