rezum M006D2201-0032Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 00191506006785), received between Aug 24, 2021 and Sep 28, 2026 — classified as 1 death, 66 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (10 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 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Detachment of Device or Device Component

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50923174 ↗
• MalfunctionSep 24, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890035 ↗
• MalfunctionSep 23, 2026Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874126 ↗
• InjurySep 10, 2026Retraction Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50724886 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had water vapor energy therapy performed on (b)(6) 2023 with no device malfunctions or any serious adverse events. Six injections were performed on the right and left lobe, and 1 injection was on the middle lobe with minor bleeding in each case. On (b)(6) 2026 the patient visited the hospital for a follow up after three years. During the visit it was confirmed that there were new or worsening lower urinary tract symptoms and the patient was re-treated with the Rezum device. The procedure was completed with the Rezum device; however, a patient outcome was not reported.

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 50130948 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a water vapor therapy procedure to treat benign prostatic hyperplasia. Following the procedure, a rectal fistula developed, which was sealed with adhesive from the urinary tract side. The patient is currently under observation. The procedure was completed with this device. The patient outcome information was not reported.

  Patient problems: Fistula

  MAUDE report 50100616 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after a water vapor therapy procedure for benign prostatic hyperplasia was completed, the patient presented a bleeding, and transurethral coagulation was performed after blood transfusion. No further information about the patient and procedure outcome was provided.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50072602 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED PYELONEPHRITIS AND HYDRONEPHROSIS IN JUNE, AFTER HAVING A TRANSURETHRAL WATER VAPOR THERAPY PROCEDURE IN FEBRUARY. THERE WERE NO DEVICE PROBLEMS REPORTED. SINCE THE PROSTATE WAS NOT PARTICULARLY LARGE, ONLY 2 TO 3 SHOTS WERE ADMINISTERED. THE PATIENT IS STILL HOSPITALIZED AND UNDERGOING TESTS.

  Patient problems: Hydronephrosis; Unspecified Infection; Urinary Tract Infection

  MAUDE report 25829122 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ABSTRACT PRESENTED IN THE 133RD ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION 2026, THAT A STUDY WAS CONDUCTED TO INVESTIGATE THE EFFICACY AND SAFETY OF PATIENTS WHO UNDERWENT REZUM WATER VAPOR THERMAL THERAPY PROCEDURE TO TREAT BENIGN PROSTATIC HYPERPLASIA. A TOTAL OF 58 PATIENTS, WITH MEDIAN AGE OF 73 YEARS OLD, WERE TREATED WITH REZUM BETWEEN (B)(6) 2024 AND (B)(6) 2025 AT ONE INSTITUTION IN JAPAN. FOLLOWING PROCEDURE, 1 PATIENT WHO WAS TAKING ANTICOAGULANTS PRIOR TO PROCEDURE, AND CONTINUED THE ANTICOAGULANT THERAPY DURING PROCEDURE, REQUIRED A BLADDER IRRIGATION FOR HEMATOMA REMOVAL AFTER DISCHARGE. ADDITIONALLY, 2 PATIENTS HAD AN ADDITIONAL PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE SURGERY PERFORMED AS THERE WAS INSUFFICIENT IMPROVEMENT FROM THE INITIAL REZUM THERAPY. URINARY RETENTION WAS OBSERVED IN 6 PATIENTS AFTER REMOVAL OF THE CATHETER THAT WAS PLACED AFTER REZUM THERAPY; HOWEVER, ALL PATIENTS IMPROVED AFTER REINSERTION AND REMOVAL OF THE CATHETER.

  Patient problems: Hematoma; Urinary Retention

  MAUDE report 25261877 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A CONFERENCE ABSTRACT THAT A STUDY WAS CONDUCTED TO INVESTIGATE POSTOPERATIVE MORPHOLOGICAL CHANGES AND INTRAPROSTATIC VAPOR DISTRIBUTION FOLLOWING WATER VAPOR ENERGY THERAPY (WAVE) FOR BENIGN PROSTATIC HYPERPLASIA (BPH) USING CYSTOSCOPY. THE STUDY INCLUDED 42 PATIENTS WHO UNDERWENT WAVE BY A SINGLE SURGEON BETWEEN (B)(6) 2024 AND (B)(6) 2025, WITH 9 PATIENTS ANALYZED AFTER UNDERGOING CYSTOSCOPY 3-6 MONTHS POSTOPERATIVELY DUE TO QUESTIONABLE SYMPTOM IMPROVEMENT AFTER WAVE. PATIENT AGE RANGED FROM 75 TO 83 YEARS, PROSTATE VOLUME RANGED FROM 30 TO 54 ML, AND ONE TO TWO PUNCTURES PER LOBE WERE PERFORMED. CYSTOSCOPIC FINDINGS AND SYMPTOM SCORES, INCLUDING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), IPSS-QUALITY OF LIFE (IPSS-QOL), AND OVERACTIVE BLADDER SYMPTOM SCORE (OABSS), WERE EVALUATED. CYSTOSCOPY REVEALED HETEROGENEOUS VAPOR SPREAD IN SEVERAL CASES, AND IN ONE PATIENT, VAPOR UNEXPECTEDLY EXTENDED THROUGH THE EJACULATORY DUCT, CAUSING MUCOSAL WHITENING AND CAVITY FORMATION. ADDITIONAL FINDINGS OBTAINED DURING CONFERENCE ATTENDANCE INDICATED THAT ONE CASE INVOLVED CALCULUS FORMATION, FOUR CASES SHOWED INSUFFICIENT IMPROVEMENT OF LOWER URINA

  Patient problems: Calcium Deposits/Calcification; Micturition Urgency; Unspecified Tissue Injury

  MAUDE report 25261864 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ABSTRACT PRESENTED AT THE 133RD ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION IN 2026, THAT RETROSPECTIVE STUDY WAS PERFORMED TO REVIEW THE OUTCOMES OF PATIENTS TREATED WITH REZUM WATER VAPOR THERAPY PROCEDURE TO TREAT BENIGN PROSTATIC HYPERPLASIA. A TOTAL OF 15 PATIENTS, WITH MEDIAN AGE OF 81 YEARS, WERE TREATED WITH REZUM BETWEEN (B)(6) 2025 AT ONE INSTITUTION IN JAPAN. FOLLOWING PROCEDURE, ONE PATIENT HAD URINARY TRACT INFECTION (UTI), AND ONE PATIENT HAD UTI AND URINARY RETENTION. THIS RECORD ADDRESSES THE PATIENT WHO EXPERIENCED ONLY THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 25260085 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE THAT A RETROSPECTIVE STUDY CONDUCTED BETWEEN JULY 2023 AND JUNE 2025 EVALUATED THE SAFETY AND EFFICACY OF TRANSURETHRAL WATER VAPOR ENERGY THERAPY (WAVE) IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA WHO ALSO HAD PROSTATE CANCER. A TOTAL OF 8 PATIENTS AGED 66 TO 83 YEARS (MEDIAN 75) WERE INCLUDED FROM A LARGER COHORT OF 189 PATIENTS. WAVE WAS PERFORMED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA AND NOT FOR PROSTATE CANCER. ONE ADVERSE EVENT OF TRANSIENT HEMATURIA WITH CLOTS FOLLOWING CATHETER REMOVAL WAS REPORTED IN A PATIENT RECEIVING ANTICOAGULANT THERAPY WHO UNDERWENT CONCURRENT BIOPSY. NO DEVICE MALFUNCTIONS WERE REPORTED.

  Patient problems: Hematuria

  MAUDE report 25260069 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE THAT AN INITIAL EXPERIENCE STUDY CONDUCTED BETWEEN OCTOBER 2023 AND JULY 2025 EVALUATED THE CLINICAL EFFICACY AND SAFETY OF TRANSURETHRAL WATER VAPOR ENERGY THERAPY (WAVE) PERFORMED AS A DAY SURGERY IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA. A TOTAL OF 21 PATIENTS WERE INCLUDED, WITH 20 PATIENTS EVALUATED, AND A MEDIAN AGE OF 80 YEARS (RANGE 49-94). REPORTED POSTOPERATIVE COMPLICATIONS INCLUDED URINARY RETENTION IN FOUR PATIENTS, EPIDIDYMITIS IN ONE PATIENT, PROSTATITIS IN ONE PATIENT, AND RETROGRADE EJACULATION REQUIRING ADDITIONAL SURGICAL INTERVENTION VIA TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) IN ONE PATIENT. OF THE URINARY RETENTION CASES, ONE WAS ATTRIBUTED TO COLLAPSE OF THE ANTERIOR FIBROMUSCULAR STROMA, WHILE THE REMAINING CASES WERE ASSOCIATED WITH EARLY CATHETER REMOVAL OR TRANSIENT POSTOPERATIVE RETENTION. NO DEVICE MALFUNCTIONS WERE REPORTED.

  Patient problems: Inflammation; Sexual Dysfunction; Urinary Retention

  MAUDE report 25260056 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ABSTRACT PRESENTED AT THE 133RD ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION IN 2026, THAT RETROSPECTIVE STUDY WAS PERFORMED TO REVIEW THE OUTCOMES OF PATIENTS TREATED WITH REZUM WATER VAPOR THERAPY PROCEDURE TO TREAT BENIGN PROSTATIC HYPERPLASIA. A TOTAL OF 15 PATIENTS, WITH MEDIAN AGE OF 81 YEARS, WERE TREATED WITH REZUM BETWEEN JANUARY AND SEPTEMBER 2025 AT ONE INSTITUTION IN JAPAN. FOLLOWING PROCEDURE, ONE PATIENT HAD URINARY TRACT INFECTION (UTI), AND ONE PATIENT HAD UTI AND URINARY RETENTION. THIS RECORD ADDRESSES THE PATIENT WHO EXPERIENCED THE UTI AND URINARY RETENTION.

  Patient problems: Urinary Retention; Urinary Tract Infection

  MAUDE report 25260040 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PRESENTED ON THE 133RD ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION, THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO ASSESS REQUIRED RE-OPERATION, AFTER A WATER VAPOR THERMAL THERAPY PROCEDURE USING REZUM TO TREAT BENIGN PROSTATIC HYPERPLASIA. DATA FROM PATIENTS THAT UNDERWENT REZUM THERAPY FROM 01JUNE2024 TO 30JULY2025 AT 1 INSTITUTION IN JAPAN INDICATED THAT 3 PATIENTS REQUIRED RE-OPERATION. CASE 1 WAS AN 80S MALE WHO HAD A PRIOR HISTORY OF TWO EPISODES OF URINARY RETENTION. THIS PATIENT UNDERWENT REZUM THERAPY AND BECAME CATHETER-FREE 8 DAYS AFTER PROCEDURE. HOWEVER, THIS PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS AND HIS VOIDING DYSFUNCTION PERSISTED. IMAGING REVEALED A CAVITY WHERE THE PROSTATIC ADENOMA WAS LOCATED, A THIN MEMBRANOUS URETHRAL STRUCTURE WAS LEFT. URETHRAL OBSTRUCTION DURING VOIDING WAS SUSPECTED. HIS SYMPTOMS RESOLVED AFTER A TRANSURETHRAL RESECTION OF THE PROSTATE.

  Patient problems: Micturition Urgency; Obstruction/Occlusion; Urinary Tract Infection

  MAUDE report 25260031 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PRESENTED ON THE 133RD ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION, THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO ASSESS REQUIRED RE-OPERATION, AFTER A WATER VAPOR THERMAL THERAPY PROCEDURE USING REZUM TO TREAT BENIGN PROSTATIC HYPERPLASIA. DATA FROM PATIENTS THAT UNDERWENT REZUM THERAPY FROM 01JUNE2024 TO 30JULY2025 AT 1 INSTITUTION IN JAPAN INDICATED THAT 3 PATIENTS REQUIRED RE-OPERATION. CASE 2 WAS A 70S MALE WHO UNDERWENT REZUM THERAPY. HOWEVER, HIS VOIDING DYSFUNCTION PERSISTED. CYSTOSCOPY REVEALED A BLADDER NECK CONTRACTURE. THIS PATIENT UNDERWENT TRANSURETHRAL RESECTION, WHICH IMPROVED THE PATIENT'S SUBJECTIVE FEELING, URINARY FLOW DID NOT IMPROVE SIGNIFICANTLY. THIS SUGGESTED THAT THE PATIENT HAD A CONCURRENT NEUROGENIC BLADDER.

  Patient problems: Micturition Urgency; Stenosis

  MAUDE report 25260030 ↗
• MalfunctionMay 15, 2026Pressure Problem

  IT WAS REPORTED THAT DURING A PROCEDURE AFTER START WITH THE GENERATOR POWERED ON, THE DELIVERY DEVICE DISPLAYS THE ERROR 241 - HIGH WATER PRESSURE (PRIME). THE SYSTEM CHECKS WERE PERFORMED AGAIN, AND THE HANDPIECE WAS REPLACED; HOWEVER, THE PROBLEM PERSISTED. THIS EVENT OCCURRED OUTSIDE THE PATIENT. CONSEQUENTLY, THE PROCEDURE COULD NOT BE COMPLETED. THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN. THIS REPORT REFERS TO THE SECOND DELIVERY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186958 ↗
• MalfunctionMay 14, 2026Pressure Problem

  IT WAS REPORTED THAT DURING A PROCEDURE AFTER START WITH THE GENERATOR POWERED ON, THE DELIVERY DEVICE DISPLAYS THE ERROR 241 - HIGH WATER PRESSURE (PRIME). THE SYSTEM CHECKS WERE PERFORMED AGAIN, AND THE HANDPIECE WAS REPLACED; HOWEVER, THE PROBLEM PERSISTED. THIS EVENT OCCURRED OUTSIDE THE PATIENT. CONSEQUENTLY, THE PROCEDURE COULD NOT BE COMPLETED. THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN. THIS REPORT REFERS TO THE FIRST DELIVERY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178955 ↗
• MalfunctionApr 7, 2026Material Fragmentation

  IT WAS REPORTED THAT, THE LEFT SIDE IS BROKEN, AND THE RIGHT SIDE IS CRACKED. IT WAS NOTED THAT THIS WAS CONFIRMED WITH AN ENDOSCOPE CAMERA. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807805 ↗
• MalfunctionApr 6, 2026Temperature Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE FIRST DELIVERY DEVICE USED DISPLAYED AN ERROR CODE 235- LOW TEMPERATURE (PRIME). THE DEVICE WAS ATTEMPTED TO BE USED SEVERAL TIMES, BUT THE ERROR PERSISTED. A SECOND DELIVERY DEVICE WAS OPENED, BUT THE SAME ERROR CODE 235 WAS SHOWED. THERE WERE NO PATIENT COMPLICATIONS; HOWEVER, THE CASE WAS NOT COMPLETED. 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 24793362 ↗
• MalfunctionApr 6, 2026Temperature Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE FIRST DELIVERY DEVICE USED DISPLAYED AN ERROR CODE 235-LOW TEMPERATURE (PRIME). THE DEVICE WAS ATTEMPTED TO BE USED SEVERAL TIMES, BUT THE ERROR PERSISTED. A SECOND DELIVERY DEVICE WAS OPENED, BUT THE SAME ERROR CODE 235 WAS SHOWED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DELIVERY DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793360 ↗
• MalfunctionApr 2, 2026Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PROCEDURE, AN ERROR CODE 275 (SYRINGE WATER FILL ERROR) OCCURRED REPEATEDLY. THE PROCEDURE WAS NOT COMPLETED DUE AND WAS RESCHEDULED FOR A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. 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 24770255 ↗
• MalfunctionApr 2, 2026Mechanical Problem; Nonstandard Device; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PROCEDURE, AN ERROR CODE 375 OCCURRED REPEATEDLY. IT WAS INDICATED THAT THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. THERE WERE NO PATIENT COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770253 ↗
• MalfunctionApr 2, 2026Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PROCEDURE, AN ERROR CODE 375 OCCURRED REPEATEDLY. IT WAS INDICATED THAT THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. THERE WERE NO PATIENT COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. 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 24770246 ↗
• MalfunctionMar 30, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY TREATMENT, THE NEEDLE COULD NO LONGER BE REMOVED, AND IT WAS RESOLVED BY PHYSICALLY BREAKING THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DELIVERY DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731354 ↗