BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 23894862 · Received December 26, 2025

    Report

    Report Number
    2124215-2025-93085
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    April 1, 2022
    Report Date
    January 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HARRINGTON, C., MOYNAGH, N., & DALY, P. (2025). OUTCOMES OF REZUM WATER VAPOUR THERAPY FOR BENIGN PROSTATIC HYPERPLASIA: A THREE-YEAR SINGLE CENTRE EXPERIENCE. EUROPEAN UROLOGY OPEN SCIENCE, 80, S8-S9. HTTPS://DOI.ORG/10.1016/S2666-1683(25)01334-5. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    HARRINGTON, C., MOYNAGH, N., & DALY, P. (2025). OUTCOMES OF REZUM WATER VAPOUR THERAPY FOR BENIGN PROSTATIC HYPERPLASIA: A THREE-YEAR SINGLE CENTRE EXPERIENCE. EUROPEAN UROLOGY OPEN SCIENCE, 80, S8-S9. HTTPS://DOI.ORG/10.1016/S2666-1683(25)01334-5. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE EUROPEAN UROLOGY OPEN SCIENCE THAT A RETROSPECTIVE ANALYSIS WAS CONDUCTED TO OF IS PROSPECTIVELY MAINTAINED DATABASE OF 100 CONSECUTIVE PATIENTS WHO UNDERWENT REZUM THERAPY BETWEEN (B)(6) 2022 AND (B)(6) 2025. DATA COLLECTED INCLUDED AGE, CHARLSON COMORBIDITY INDEX (CCI), PROSTATE VOLUME ON MRI, BASELINE IPSS, AND UROFLOWMETRY (QMAX). INTRAOPERATIVE DATA INCLUDED NUMBER OF TREATMENTS. POST-OPERATIVE FOLLOW-UP AT 3 MONTHS ASSESSED IPSS, QMAX, POST-VOID RESIDUAL (PVR). WE ASSESSED 30-DAY COMPLICATIONS, AND NEED FOR SUBSEQUENT TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE MEDIAN PATIENT AGE WAS 70.5 YEARS, WITH A MEDIAN CCI OF 2. MEDIAN PROSTATE VOLUME WAS 52 CC. BASELINE MEDIAN IPSS WAS 18 AND 4 FOR QUALITY OF LIFE (QOL); QMAX 11 ML/S, AND PVR 128 ML. MEDIAN NUMBER OF TREATMENTS WAS 7. AT 3-MONTH FOLLOW-UP, MEDIAN IPSS IMPROVED TO 7 AND 2 FOR QOL. ON UROFLOWMETRY, QMAX IMPROVED TO 15 ML/S WITH A MEAN CHANGE +6 ML/S, AND PVR TO 42 ML. THE COMPLICATION RATE WAS 3%, AND 7% OF PATIENTS REQUIRED TURP FOR MEDIAN LOBE NECROSIS. REZUM IS A SAFE, EFFECTIVE TREATMENT FOR BPH IN SELECTED PATIENTS, DEMONSTRATING DURABLE SYMPTOM RELIEF AND LOW COMPLICATION RATES IN OUR PRACTICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE EUROPEAN UROLOGY OPEN SCIENCE THAT A RETROSPECTIVE ANALYSIS WAS CONDUCTED TO OF IS PROSPECTIVELY MAINTAINED DATABASE OF 100 CONSECUTIVE PATIENTS WHO UNDERWENT REZUM THERAPY BETWEEN APRIL 2022 AND APRIL 2025. DATA COLLECTED INCLUDED AGE, CHARLSON COMORBIDITY INDEX (CCI), PROSTATE VOLUME ON MRI, BASELINE IPSS, AND UROFLOWMETRY (QMAX). INTRAOPERATIVE DATA INCLUDED NUMBER OF TREATMENTS. POST-OPERATIVE FOLLOW-UP AT 3 MONTHS ASSESSED IPSS, QMAX, POST-VOID RESIDUAL (PVR). WE ASSESSED 30-DAY COMPLICATIONS, AND NEED FOR SUBSEQUENT TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE MEDIAN PATIENT AGE WAS 70.5 YEARS, WITH A MEDIAN CCI OF 2. MEDIAN PROSTATE VOLUME WAS 52 CC. BASELINE MEDIAN IPSS WAS 18 AND 4 FOR QUALITY OF LIFE (QOL); QMAX 11 ML/S, AND PVR 128 ML. MEDIAN NUMBER OF TREATMENTS WAS 7. AT 3-MONTH FOLLOW-UP, MEDIAN IPSS IMPROVED TO 7 AND 2 FOR QOL. ON UROFLOWMETRY, QMAX IMPROVED TO 15 ML/S WITH A MEAN CHANGE +6 ML/S, AND PVR TO 42 ML. THE COMPLICATION RATE WAS 3%, AND 7% OF PATIENTS REQUIRED TURP FOR MEDIAN LOBE NECROSIS. REZUM IS A SAFE, EFFECTIVE TREATMENT FOR BPH IN SELECTED PATIENTS, DEMONSTRATING DURABLE SYMPTOM RELIEF AND LOW COMPLICATION RATES IN OUR PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786604 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention