rezum Generator G2200-003DRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729986850), received between Dec 11, 2019 and Feb 12, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE UNIT STOPPED IN MIDDLE OF THE WATER VAPOR THERAPY PROCEDURE. THE SALINE SOLUTION WAS RESTOCKED, AND THE UNIT REPRIMED, BUT STILL NOT WORKED. THEREFORE, THE PROCEDURE COULD NOT BE COMPLETED. 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 21364150 ↗
• MalfunctionFeb 3, 2025Poor Quality Image; Noise, Audible; Unexpected Shutdown; Poor Quality Image; Noise, Audible; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE, AFTER APPLYING THREE TREATMENTS THERE WAS AN ISSUE WITH THE GENERATOR CAUSING THE SCREEN TO GLITCH, THE SYSTEM TO TURN OFF, AND THERE WAS A BEEPING SOUND. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293239 ↗
• MalfunctionAug 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING THE PRIMING PROCESS, ERROR CODE 275 WAS ISSUED REPEATEDLY. TWO DIFFERENT DEVICES WERE TRIED BUT THE SAME ERROR CODE PERSISTED. IT WAS NOTED THAT THE ISSUE IS LIKELY RELATED TO A FAULT WITH THE GENERATOR. THE PROCEDURE WAS CANCELLED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975847 ↗
• MalfunctionFeb 9, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THREE DIFFERENT DELIVERY DEVICES PRESENTED WITH ERROR CODE 218 (DEVICE IMPEDANCE). THE PROCEDURE WAS CANCELLED WITHOUT PATIENT COMPLICATIONS. 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 18679901 ↗
• MalfunctionFeb 5, 2024Retraction Problem; Adverse Event Without Identified Device or Use Problem; Retraction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DURING A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, FOUR KITS WERE OPENED AND WITH ALL OF THEM, THE GENERATOR DISPLAYED ERROR CODE 296 FAULTY DELIVERY DEVICE: NEEDLE RETRACTION ERROR. THE MANUAL RETRACTION WAS SUCCESSFUL, BUT THE NEEDLE WOULD NOT RE DEPLOY. THE GENERATOR WAS TURNED ON AND OFF, BUT THE PROCEDURE COULD NOT BE COMPLETED. 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 18645412 ↗
• MalfunctionJan 16, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE ERROR 480 (SENSOR INTERFACE ERROR) WAS DISPLAYED AND THE NEEDLE WAS TRIED TO BE RETRACTED NUMEROUS TIMES, BUT THE ERROR PERSISTED. THE DEVICE WAS SHUT DOWN AND TRIED MULTIPLES OUTLETS MANY TIMES, AND THE ERROR WAS NOT CLEARED. DUE TO THIS, THE PROCEDURE WAS NOT COMPLETED. 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 18522434 ↗
• MalfunctionJan 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE GENERATOR DISPLAYED AN ERROR CODE 480 AND A MESSAGE THAT STATES: RETRACT NEEDLE AND REMOVE THE DELIVERY DEVICE FROM PATIENT, POWER OFF/ON THE GENERATOR IF PROBLEM PERSISTS., WHICH ASKED TO RETRACT THE NEEDLE AND REMOVE THE DEVICE, BUT THE DELIVERY DEVICE WAS NOT EVEN ATTACHED OR CONNECTED. THE GENERATOR WAS UNPLUGGED AND PLUGGED BACK BUT THE ISSUE PERSISTED. 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 18480486 ↗
• MalfunctionMar 17, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE UNIT WAS HAVING AN ERROR CODE. THE ISSUE COULD NOT BE RESOLVED, AND THE PROCEDURE WAS CANCELLED WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564619 ↗
• MalfunctionSep 30, 2022Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE GENERATOR DISPLAYED ERROR MESSAGE 40000. THE FACILITY POWER CYCLED AND REBOOTED THE GENERATOR, BUT WAS UNABLE TO CLEAR THE ERROR MESSAGE. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519371 ↗
• MalfunctionAug 19, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT FOLLOWING SEDATION OF THE PATIENT, THIS REZUM GENERATOR DISPLAYED A RED LIGHT AND MESSAGE TO CALL SUPPORT/REPLACE THE UNIT. AN UNSPECIFIED ERROR MESSAGE WAS OBSERVED AND RESTARTING THE GENERATOR WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. AS A RESULT, THE PROCEDURE WAS CANCELED TO BE RESCHEDULED ON ANOTHER DATE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259663 ↗
• MalfunctionApr 7, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE, THE GENERATOR WORKED FOR 8 SECONDS BEFORE ENCOUNTERING ERROR CODE 270 (SYRINGE EMPTY). HOWEVER, THE SYRINGE WAS NOT EMPTY AT ALL. THERE WAS NO PATIENT COMPLICATION DUE TO THIS EVENT AND THE PROCEDURE WAS ABORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047173 ↗
• MalfunctionNov 10, 2021Retraction Problem; Material Integrity Problem; Retraction Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERMAL THERAPY PROCEDURE ERROR CODE 296: NEEDLE RETRACTION ERROR WAS DISPLAYED AFTER FORCEFULLY PUSHING THE RF CABLE IN. TROUBLESHOOTING WAS ATTEMPTED BY REBOOTING THE SYSTEM SEVERAL TIMES, BUT THE CODE KEPT DISPLAYING. THE NEEDLE WAS MANUALLY RETRACTED, AND THE DELIVERY DEVICE EXCHANGED. HOWEVER, THE PROBLEM REOCCURRED WITH THE SECOND DELIVERY DEVICE. REBOOTING WAS ATTEMPTED ONCE MORE TO NO AVAIL. IT WAS INITIALLY THOUGHT THAT THE PROBLEM WAS IN THE DELIVERY DEVICE BUT AFTER IT HAD BEEN REPLACED, THE SAME PROBLEM WAS SEEN. THEREFORE, THE PROBLEM WAS SUSPECTED TO BE CAUSED BY THE CONNECTION WITH THE GENERATOR AND THERE ARE NO DEVICE ISSUES WITH THE DELIVERY DEVICES. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AFTER THE PATIENT HAD BEEN ADMINISTERED GENERAL ANESTHESIA. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. THIS EVENT IS BEING REPORTED FOR AN ABORTED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788055 ↗
• MalfunctionOct 25, 2021Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DELIVERY DEVICE ERROR MESSAGE DISPLAYED UP DURING PREPARATION FOR THE PROCEDURE AND REQUIRED SET UP TWICE. AFTER SECOND SET UP SYRINGE CRADLE WASN'T REGISTERING SYRINGE IN PLACE. A SECOND DELIVERY DEVICE WAS OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS THEN CANCELLED/RESCHEDULED. THE PATIENT HAD BEEN ADMINISTERED GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688542 ↗
• MalfunctionFeb 11, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DUE TO HEAT AND SYRINGE ERRORS, THE PROCEDURE COULD NOT BE COMPLETED. THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION AFTER PREPARATION. THERE WERE NO PATIENT COMPLICATION AND THE PATIENT STATUS IS REPORTED AS GOOD FOLLOWING THIS ABORTED PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED FOLLOWING THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317995 ↗
• MalfunctionJan 27, 2021Adverse Event Without Identified Device or Use Problem; Power Problem; Adverse Event Without Identified Device or Use Problem; Power Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A WATER VAPOR THERAPY OF A PROSTATE PROCEDURE, THE DELIVERY DEVICE WAS ABLE TO PRIME THE FIRST TIME. HOWEVER, WHEN PRIMING THE DELIVERY DEVICE A SECOND TIME, ERROR CODE 495 (RADIO FREQUENCY POWER SUPPLY SELF-TEST ERROR) APPEARED ON THE GENERATOR SCREEN. THE CUSTOMER TRIED RESTARTING THE GENERATOR, BUT THE SAME ERROR APPEARED. A SECOND DEVICE DELIVERY WAS OPENED AND TRIED WITH THE SAME GENERATOR TO MAKE SURE THE PROBLEM WAS NOT DELIVERY DEVICE RELATED; HOWEVER, THE SAME ERROR APPEARED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11239947 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GENERATOR SCREEN BECAME COMPLETELY BLACK. THE PATIENT WAS UNDER ANESTHESIA WHEN THE ISSUE WAS NOTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO INJURY TO THE PATIENT OCCURRED DUE TO THIS EVENT. PATIENT CURRENT CONDITION IS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492517 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DURING A CONVECTIVE RADIOFREQUENCY WATER VAPOR THERMAL THERAPY PROCEDURE THE SCREEN HAD ORANGE LINES ACROSS AND AFTER 2 RESTARTS IT FAILED ALL TOGETHER. THE PROCEDURE WAS HALFWAY COMPLETED WHEN THE GENERATOR ISSUE OCCURRED. THE PROCEDURE WAS ABORTED WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454562 ↗