BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 23935714 · Received December 31, 2025

    Report

    Report Number
    2124215-2025-94001
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    October 31, 2020
    Report Date
    February 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. EXACT B3 DATE OF EVENT IS UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALADESURU O, AMANKWAH K, ELTERMAN D, ZORN KC, BHOJANI N, TE A, CHUGHTAI B. PILOT STUDY OF "LESS IS MORE" REZUM FOR TREATMENT OF BPH. UROLOGY. 2022 JUL; 165:256-260. DOI: 10.1016/J.UROLOGY.2022.01.039. EPUB 2022 FEB 6. PMID: 35139413.

    Additional Manufacturer Narrative · 0

    EXACT B3 DATE OF EVENT IS UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALADESURU O, AMANKWAH K, ELTERMAN D, ZORN KC, BHOJANI N, TE A, CHUGHTAI B. PILOT STUDY OF "LESS IS MORE" REZUM FOR TREATMENT OF BPH. UROLOGY. 2022 JUL; 165:256-260. DOI: 10.1016/J.UROLOGY.2022.01.039. EPUB 2022 FEB 6. PMID: 35139413.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLOGY (2022) TITLED PILOT STUDY OF LESS IS MORE REZUM FOR TREATMENT OF BPH THAT A PROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF A MODIFIED REZUM TREATMENT APPROACH CONSISTING OF A SINGLE THERMAL WATER VAPOR INJECTION PER PROSTATE LOBE FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS (LUTS) SECONDARY TO BENIGN PROSTATIC HYPERPLASIA (BPH). THE STUDY WAS CONDUCTED AT A SINGLE UROLOGIC CLINIC BETWEEN (B)(6) 2019 AND (B)(6) 2020 AND INCLUDED 52 MALE PATIENTS WITH MODERATE TO SEVERE SYMPTOMATIC BPH, WITH PROSTATE VOLUMES RANGING FROM 30 TO 80 CC, WITH AND WITHOUT MEDIAN LOBES. ALL PROCEDURES WERE PERFORMED UNDER LOCAL ANESTHESIA. REGARDING SAFETY OUTCOMES, NO SERIOUS ADVERSE EVENTS WERE REPORTED DURING THE STUDY PERIOD. FIVE PATIENTS (9.6%) FAILED THEIR INITIAL TRIAL OF VOID FOLLOWING THE PROCEDURE; HOWEVER, ALL WERE ABLE TO VOID SUCCESSFULLY WITHIN 8 DAYS POST-PROCEDURE. ONE PATIENT WITH A BASELINE PROSTATE SIZE OF 131 CC UNDERWENT RETREATMENT WITH LASER PROSTATECTOMY AT 6 MONTHS FOLLOW-UP. ONE PATIENT REPORTED EJACULATORY DYSFUNCTION AT THE 3-MONTH FOLLOW-UP. ADDITIONAL NON-SERIOUS ADVERSE EVENTS INCLUDED ONE REPORT OF INCREASED DIFFICULTY VOIDING, ONE REPORT OF HEMATURIA, AND TWO REPORTS OF DYSURIA, ALL REPORTED AT THE 1-MONTH FOLLOW-UP. THESE EVENTS WERE DESCRIBED AS MILD TO MODERATE IN SEVERITY AND TRANSIENT, RESOLVING BY THE 3-MONTH FOLLOW-UP. NO CHANGES IN ERECTILE DYSFUNCTION WERE REPORTED. AT THEIR 12 MONTH FOLLOW-UP VISITS, PATIENTS EXPERIENCED AN IMPROVEMENT IN THEIR LUTS AND BPH SYMPTOMS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLOGY (2022) TITLED PILOT STUDY OF LESS IS MORE REZUM FOR TREATMENT OF BPH THAT A PROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF A MODIFIED REZUM TREATMENT APPROACH CONSISTING OF A SINGLE THERMAL WATER VAPOR INJECTION PER PROSTATE LOBE FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS (LUTS) SECONDARY TO BENIGN PROSTATIC HYPERPLASIA (BPH). THE STUDY WAS CONDUCTED AT A SINGLE UROLOGIC CLINIC BETWEEN JANUARY 2019 AND OCTOBER 2020 AND INCLUDED 52 MALE PATIENTS WITH MODERATE TO SEVERE SYMPTOMATIC BPH, WITH PROSTATE VOLUMES RANGING FROM 30 TO 80 CC, WITH AND WITHOUT MEDIAN LOBES. ALL PROCEDURES WERE PERFORMED UNDER LOCAL ANESTHESIA. REGARDING SAFETY OUTCOMES, NO SERIOUS ADVERSE EVENTS WERE REPORTED DURING THE STUDY PERIOD. FIVE PATIENTS (9.6%) FAILED THEIR INITIAL TRIAL OF VOID FOLLOWING THE PROCEDURE; HOWEVER, ALL WERE ABLE TO VOID SUCCESSFULLY WITHIN 8 DAYS POST-PROCEDURE. ONE PATIENT WITH A BASELINE PROSTATE SIZE OF 131 CC UNDERWENT RETREATMENT WITH LASER PROSTATECTOMY AT 6 MONTHS FOLLOW-UP. ONE PATIENT REPORTED EJACULATORY DYSFUNCTION AT THE 3-MONTH FOLLOW-UP. ADDITIONAL NON-SERIOUS ADVERSE EVENTS INCLUDED ONE REPORT OF INCREASED DIFFICULTY VOIDING, ONE REPORT OF HEMATURIA, AND TWO REPORTS OF DYSURIA, ALL REPORTED AT THE 1-MONTH FOLLOW-UP. THESE EVENTS WERE DESCRIBED AS MILD TO MODERATE IN SEVERITY AND TRANSIENT, RESOLVING BY THE 3-MONTH FOLLOW-UP. NO CHANGES IN ERECTILE DYSFUNCTION WERE REPORTED. AT THEIR 12 MONTH FOLLOW-UP VISITS, PATIENTS EXPERIENCED AN IMPROVEMENT IN THEIR LUTS AND BPH SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792795 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other