BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 24606471 · Received March 16, 2026

    Report

    Report Number
    2124215-2026-14347
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    January 1, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROCHESTER, M., BARBER, N., MAZZERALLE, B., CANTRILL, C., CINMAN, A., SCHIFF, J., ROEHRBORN, C. THE COMPARING UROLIFT EXPERIENCE AGAINST REZUM (CLEAR) RCT: PRELIMINARY ANALYSES SUGGEST A SUPERIOR EARLY PATIENT EXPERIENCE WITH UROLIFT PUL (PUL). JOURNAL OF CLINICAL UROLOGY, 17(IS). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF CLINICAL UROLOGY, THAT A PROSPECTIVE STUDY WAS CONDUCTED TO COMPARE THE UROLIFT PUL (PUL) THERAPY AGAINST THE REZUM THERAPY. THE STUDY EVALUATED PATIENT EXPERIENCE, SAFETY, AND EFFICACY AGAINST BENIGN PROSTATIC HYPERPLASIA BETWEEN THE TWO THERAPIES. A TOTAL OF 33 PATIENTS WERE TREATED WITH REZUM, AND 35 PATIENTS WERE TREATED WITH PUL. THREE TO SEVEN DAYS FOLLOWING THE PROCEDURES, 26% OF PATIENTS FROM THE REZUM GROUP FAILED TO BE CATHETER-INDEPENDENT, WHILE ALL PATIENTS TREATED WITH PUL WERE CATHETER-INDEPENDENT. ADDITIONALLY, 44% OF THOSE PATIENTS WHO FAILED TO BE CATHETER-INDEPENDENT HAD RECURRENT CATHETERIZATION BY DAY 365. WITHIN ONE YEAR, 1 PATIENT FROM EACH TREATMENT GROUP UNDERWENT SURGICAL RETREATMENT. OVERALL, PATIENTS WHO RECEIVED UROLIFT PUL REPORTED HIGHER INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS) AND QUALITY OF LIFE WHEN COMPARED TO THE REZUM TREATMENT GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666209 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other