rezumRecalls & reported problems across all models

We found 2 models of rezum by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 196 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2019 and Sep 29, 2026 — classified as 1 death, 85 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported rezum problems

rezum models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• rezum M006D2201-0032

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 death113 reports
• rezum M006D2201-003

  Unit, electrosurgical, endoscopic (with or without accessories)
  83 reports

Recent rezum adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934461 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934460 ↗
• 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 ↗
• MalfunctionSep 17, 2026Premature Activation; Retraction Problem; Use of Device Problem

  It was reported that during a Convective Radiofrequency Water Vapor Thermal Therapy, after inserting the device into the patient, the needle deployed and misfired steam. After this happened, the needle would then not retract. The physician had to then pull the nose cone pin out of the device to manually retract the needle from the patient. The procedure was completed using another delivery device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805061 ↗
• InjurySep 10, 2026Retraction Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50724886 ↗
• MalfunctionSep 3, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599916 ↗
• 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 ↗

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