rezum Generator G2200Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00855357006003), received between Nov 8, 2019 and Jul 31, 2025 — classified as 1 death, 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERMAL THERAPY PROCEDURE, ERROR 495 WAS DISPLAYED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677376 ↗
• MalfunctionMay 14, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT, PRIOR TO A PROCEDURE, THE CUSTOMER OBSERVED THAT THE IRRIGATION WAS NOT FLOWING. TROUBLESHOOTING WAS PERFORMED, AND IT WAS CONFIRMED THAT THE CUSTOMER WAS FOLLOWING THE STEPS CORRECTLY. HOWEVER, IRRIGATION STILL WOULD NOT FLOW THROUGH THE DEVICE. THEN, IT WAS FURTHER ATTEMPTED TO DEPLOY THE NEEDLE IN HOPES IRRIGATION WOULD AUTOMATICALLY FLOW, BUT IT DID NOT WORK. A SECOND DELIVERY DEVICE WAS USED AND HAD THE SAME IRRIGATION ISSUE. IT WAS NOTED THAT THIS IS LIKELY A ROLLER PUMP ISSUE WITH THE GENERATOR. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS ALREADY UNDER GENERAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS. 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 22022772 ↗
• MalfunctionApr 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS AN IRRIGATION AND ROLLER PUMP ISSUE WITH THE SYSTEM, AS BEFORE TO THE PROCEDURE BEGINNING AND BEFORE INSERTING THE DEVICE INTO THE PATIENT, THE PHYSICIAN NOTICED THAT THE SALINE WAS NOT FLOWING. A DIFFERENT HANDPIECE WAS USED, BUT THE ISSUE PERSISTS. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911558 ↗
• MalfunctionDec 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE GENERATOR WAS NOT RECOGNIZING DELIVERY DEVICES DURING THE CONVECTIVE RADIOFREQUENCY WATER VAPOR THERMAL THERAPY PROCEDURE. 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 20926888 ↗
• MalfunctionDec 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE, THE GENERATOR DID NOT ALLOW THE PHYSICIAN TO PERFORM THE SECOND PRIME, OTHER KITS WERE OPENED BUT THE PROBLEM PERSISTED. THE PROCEDURE HAD TO BE CANCELED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857946 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WATER VAPOR THERAPY PROCEDURE WAS PERFORMED WITHOUT DEVICE ISSUES OR PATIENT COMPLICATIONS. FOUR STEAM INJECTIONS WERE PERFORMED ON THE RIGHT LOBE AND FOUR ON THE LEFT LOBE, WITH MINOR BLEEDING IN EACH CASE. NO INJECTIONS WERE PERFORMED IN THE MIDDLE LOBE. HOWEVER, ALMOST A YEAR AFTER TREATMENT THE PATIENT EXPERIENCED MILD URINARY URGENCY, HENCE, MEDICATION WAS ADMINISTERED. THE MEDICATION USED WAS AN ANDROGENIC RECEPTOR BLOCKER. IT WAS STATED THAT THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY TO THE PROCEDURE.

  Patient problems: Micturition Urgency

  MAUDE report 19756903 ↗
• DeathFeb 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT A WATER VAPOR THERAPY (WAVE) PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA. THE PATIENT DEVELOPED A FEVER LAST DECEMBER AND WAS RUSHED TO THE HOSPITAL. IT WAS SUSPECTED THAT AN INFECTION WAS DEVELOPED AFTER THE WAVE PROCEDURE. THE INFECTION WAS TREATED AT THE HOSPITAL. IN JANUARY, THE PATIENT HAD A RUPTURE OF AN INFECTED ANEURYSM (ANEURYSM CAUSED BY DESTRUCTION OF THE ARTERIAL WALL STRUCTURE DUE TO INFECTION), WHICH CAUSED A SUDDEN CHANGE IN THE PATIENTS CONDITION WHICH LED TO HIS DEATH. THE PHYSICIAN SUSPECTED THAT THE INFECTION MIGHT HAVE BEEN CAUSED BY THE WAVE PROCEDURE, HOWEVER, THE INFORMATION ON WHEN THE PROCEDURE WAS PERFORMED WAS NOT AVAILABLE.

  Patient problems: Ruptured Aneurysm; Unspecified Infection

  MAUDE report 18651027 ↗
• MalfunctionMar 1, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN GIVEN GENERAL ANESTHESIA PRIOR TO A WATER VAPOR THERAPY PROCEDURE. DURING PREPARATION FOR THE PROCEDURE. ERROR 455 (SALINE PUMP SELF-TEST ERROR) OCCURRED. THE UNIT WAS TURNED OFF AND THEN ON AGAIN, BUT THE ERROR DID NOT RESOLVE. THE PROCEDURE WAS THEN CANCELLED. 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 16464157 ↗
• MalfunctionDec 15, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A WATER VAPOR THERAPY PROCEDURE, THAT THE GENERATOR ENCOUNTERED CONTINUOUS PRIME ERROR MESSAGES WITH TWO DELIVERY DEVICES. 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 15992523 ↗
• MalfunctionNov 7, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE LAST 3 PROCEDURES THE GENERATOR HAS BEEN GIVING ERROR CODES LIKE BUBBLES IN THE LINE AND RETRACT THE NEEDLE AND REMOVE DELIVERY DEVICE FROM PATIENT. DURING A PROCEDURE THE MESSAGE RETRACT THE NEEDLE AND REMOVE DELIVERY DEVICE FROM PATIENT APPEARED HALFWAY THROUGH TREATMENT AND THE PROCEDURE WAS CANCELLED. NOW THE ERROR LIGHT IS CONSTANTLY ON, AND PROCEDURES CAN'T BE DONE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743445 ↗
• 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 ERROR CODE 40000 (GUI UNABLE TO COMMUNICATION WITH MCU) DISPLAYED ON THE GENERATOR SCREEN. A NEW DELIVERY DEVICE WAS CHOSEN TO CONTINUE WITH THE PROCESS, AND THE GENERATOR WAS TURN OFF AND POWERED BACK, BUT THE SAME ERROR CODE CONTINUED TO OCCUR. 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 15520104 ↗
• MalfunctionJan 28, 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 DURING A WATER VAPOR THERAPY PROCEDURE, THE GENERATOR PROMPTED AN ERROR CODE INDICATING THAT IT NEEDS SERVICE. THERE WERE NO PATIENT COMPLICATIONS; HOWEVER, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386139 ↗
• MalfunctionNov 22, 2021Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING PREPARATION FOR A WATER VAPOR THERAPY PROCEDURE, ERROR 450 WAS RECEIVED STATING THE DEVICE NEEDS TO BE REPLACED/SERVICED DUE TO AN ERROR CODE. THE PATIENT HAD BEEN SEDATED AT THE TIME. THE EVENT OCCURRED OUTSIDE THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. THIS EVENT IS BEING REPORTED FOR PROCEDURE ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858401 ↗
• MalfunctionSep 21, 2021Retraction Problem; Device Displays Incorrect Message; Communication or Transmission Problem; Retraction Problem; Device Displays Incorrect Message; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A WATER VAPOR THERAPY, THE GENERATOR DID TO RETRACT THE NEEDLE WHEN THE DELIVERY DEVICE WAS PLUGGED. IT WAS NOTED THAT ERROR MESSAGE CODE 40000 MESSAGE OCCURRED. THERE WAS NO PATIENT COMPLICATION DUE TO THIS EVENT; HOWEVER, THE PATIENT HAD ALREADY BEING SEDATED. THE PROCEDURE WAS CANCELED, AND THE PATIENT WAS RESCHEDULED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509342 ↗
• MalfunctionSep 14, 2021No Display/Image; Adverse Event Without Identified Device or Use Problem; No Display/Image; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT THE DISPLAY ONLY APPEARED ON HALF THE SCREEN AND THEN FADED OUT. THE CONSOLE CANNOT BE USED FOR CASES. IT WAS INDICATED THAT THE EVENT OCCURRED WHEN THEY TRIED TO START THE GENERATOR, BEFORE THEY STARTED USING IT ON A PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470757 ↗
• MalfunctionAug 12, 2021No Display/Image; Material Integrity Problem; No Display/Image; Material Integrity Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR TWO SEPARATE WATER VAPOR THERAPY PROCEDURE CASES, THE SCREEN ON THE GENERATOR TURNED BLUE DURING PRIMING OF THE DELIVERY DEVICE. THE STAFF REBOOTED THE GENERATOR AND WERE ABLE TO PERFORM A FEW TREATMENTS. HOWEVER, THE GENERATOR SCREEN TURNED BLUE AGAIN. THE GENERATOR WAS TURNED OFF, UNPLUGGED FROM THE WALL AND ALL CONNECTIONS WERE CHECKED. THE ISSUE DID NOT RESOLVE, AND IN BOTH INSTANCES, THE PROCEDURE WAS ABORTED. THERE WERE NO COMPLICATIONS TO THE PATIENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA. THIS REPORT IS FOR 2 OF 2 PROCEDURES IN WHICH THE GENERATOR WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314412 ↗
• MalfunctionAug 12, 2021No Display/Image; Material Integrity Problem; No Display/Image; Material Integrity Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR TWO SEPARATE WATER VAPOR THERAPY PROCEDURE CASES, THE SCREEN ON THE GENERATOR TURNED BLUE DURING PRIMING OF THE DELIVERY DEVICE. THE STAFF REBOOTED THE GENERATOR AND WERE ABLE TO PERFORM A FEW TREATMENTS. HOWEVER, THE GENERATOR SCREEN TURNED BLUE AGAIN. THE GENERATOR WAS TURNED OFF, UNPLUGGED FROM THE WALL AND ALL CONNECTIONS WERE CHECKED. THE ISSUE DID NOT RESOLVE, AND IN BOTH INSTANCES, THE PROCEDURE WAS ABORTED. THERE WERE NO COMPLICATIONS TO THE PATIENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA. THIS REPORT IS FOR 1 OF 2 PROCEDURES IN WHICH THE GENERATOR WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313754 ↗
• MalfunctionNov 2, 2020No Display/Image; Material Integrity Problem; No Display/Image; Material Integrity Problem

  IT WAS REPORTED THAT DURING PREPARATION OF CONVECTIVE RADIOFREQUENCY WATER VAPOR THERMAL THERAPY, THE GENERATOR BOOTED OK, GOT TO PRIME AND THEN GENERATOR SCREEN STARTED FLASHING. THERE WAS NO IMAGE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT CONDITION WAS REPORTED TO BE GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10770857 ↗
• MalfunctionJun 4, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE CONVECTIVE RADIOFREQUENCY WATER VAPOR THERMAL THERAPY PROCEDURE THE GENERATOR RECEIVED ERROR 400. TWO DEVICES WERE USED TO TROUBLESHOOT THE GENERATOR ISSUE WHILE THE PATIENT WAS AWAITED TREATMENT. THE PATIENT WAS IN POST SEDATION UNDER A LOCAL ANESTHESIA. THE PATIENT HAD TO BE RESCHEDULED DUE TO THE ISSUES WITH THE EQUIPMENT. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10121218 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PRETREATMENT, WITH A PATIENT UNDER ANESTHESIA, A CODE WAS RECEIVED TO REPLACE THE DELIVERY DEVICE FOR THE FIRST TWO DEVICES USED. A THIRD AND FOURTH DELIVERY DEVICE WERE TRIED BUT BOTH DEVICES WERE NOT RECOGNIZED AND NO CODE WAS RECEIVED. THE PROCEDURE WAS NOT COMPLETED AS A RESULT OF THE DEVICE ISSUES. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742211 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYSTEM POWERED UP WITH ERROR CODE 480 (SENSOR INTERFACE ERROR) INDICATING REMOVE DELIVERY DEVICE BUT NO DELIVERY DEVICE WAS PLUGGED IN. TURNED THE GENERATOR OFF AND ON BUT THE ISSUE WAS NOT RESOLVED. PROCEDURE WAS CANCELED. NO COMPLICATIONS TO THE PATIENT OCCURRED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9496664 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS PRESENT AND HAD RECEIVED A TRUS, INCLUDING A MODIFIED PROSTATE BLOCK WITH LIDOCAINE IN ADDITION TO LIDOCAINE JELLY IN THE URETHRA PRIOR TO WATER VAPOR THERAPY PROCEDURE. DURING THE INITIAL DEVICE SET-UP THERE WAS NO INDICATION THAT ANYTHING WAS WRONG UNTIL PERFORMING THE PRETREATMENT CYCLE. STEAM DID NOT EXIT THE TIP OF THE DEVICE AND ERROR CODES BEGAN TO POP UP REGARDING THE RFCABLE PORT AND REPLACING WITH A NEW DEVICE. AFTER OPENING A SECOND DEVICE AND RESTARTING THE GENERATOR ERROR CODE 4000 WAS PROMPTED ON THE CONSOLE. THE ERROR COULD NOT BE BYPASSED AND THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9406599 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS GIVING ERROR MESSAGE. THE GENERATOR WAS REBOOTED SEVERAL TIMES AND THE SAME MESSAGE CAME UP WITH THE SAME ERROR MESSAGE. A PATIENT WAS REPORTED TO BE INVOLVED AT THE TIME OF THE OBSERVED ISSUES. THE PROCEDURE WAS NOT COMPLETED DO TO THE REPORTED EVENT. THERE WAS NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376883 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GENERATOR WAS GIVING THE ERROR MESSAGE "DELIVERY DEVICE IS EXPIRED." THE UNIT WAS REBOOTED AND THE DEVICE WAS REINSERTED. THE MESSAGE STILL PERSISTS. THEY DID NOT HAVE ANOTHER DELIVERY DEVICE. THE PROCEDURE WAS ABORTED; THERE WAS A PATIENT INVOLVED AT THE TIME THE PROCEDURE WAS CANCELLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297230 ↗