rezum D2201Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00855357006010), received between Jun 20, 2024 and Aug 20, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Retraction Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FOLLOW-UP MEETING WITH A UROLOGIST ON UNRELATED MATTERS, THE PHYSICIAN MENTIONED THAT 2 OF HIS PRIVATE PATIENTS, THAT HAD THE REZUM PROCEDURE IN THE LAST 6 MONTHS, HAVE ENDED UP WITH AN ENTEROCOCCUS INFECTION. BOTH PATIENTS REQUIRED LONG TERM ANTIBIOTICS. ONE PATIENT MAY STILL BE ON THE ANTIBIOTICS. ACCORDING TO THE PHYSICIAN, INJURIES MAY HAVE BEEN CAUSED FROM INFECTION IN THE COAGULATIVE NECROTIC MATERIAL LEFT AFTER THE REZUM PROCEDURE THAT POTENTIALLY HARBORED BACTERIA MOBILIZED AFTER THE INDWELLING URETHRAL CATHETER REMOVAL. THIS IS 1 OF 2 PATIENT REPORTS.

  Patient problems: Bacterial Infection

  MAUDE report 20001214 ↗
• InjuryAug 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FOLLOW-UP MEETING WITH A UROLOGIST ON UNRELATED MATTERS, THE PHYSICIAN MENTIONED THAT 2 OF HIS PRIVATE PATIENTS, THAT HAD THE REZUM PROCEDURE IN THE LAST 6 MONTHS, HAVE ENDED UP WITH AN ENTEROCOCCUS INFECTION. BOTH PATIENTS REQUIRED LONG TERM ANTIBIOTICS. ONE PATIENT MAY STILL BE ON THE ANTIBIOTICS. ACCORDING TO THE PHYSICIAN, INJURIES MAY HAVE BEEN CAUSED FROM INFECTION IN THE COAGULATIVE NECROTIC MATERIAL LEFT AFTER THE REZUM PROCEDURE THAT POTENTIALLY HARBORED BACTERIA MOBILIZED AFTER THE INDWELLING URETHRAL CATHETER REMOVAL. THIS IS 2 OF 2 PATIENT REPORTS.

  Patient problems: Bacterial Infection

  MAUDE report 20000018 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A WATER VAPOR THERMAL THERAPY PROCEDURE, AT TWO MONTHS, THE PATIENT HAS EXPERIENCED PROBLEMS WITH URINARY URGENCY. IT WAS ALSO REPORTED THE PATIENT FELT PAIN AND DISCOMFORT.

  Patient problems: Discomfort; Micturition Urgency; Pain

  MAUDE report 19967484 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE WATER VAPOR THERMAL THERAPY PROCEDURE FOUR PATIENTS EXPERIENCED AN INFECTION, ONE OF THE PATIENTS DEVELOPED SEPSIS SEVERAL DAYS AFTER THE INDWELLING CATHETER WAS REMOVED, THEREFORE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), TWO PATIENTS WERE ADMITTED TO HOSPITAL WITH SEVERE INFECTION AND WERE TREATED WITH INTRAVENOUS ANTIBIOTICS, THE LAST PATIENT REQUIRED ORAL ANTIBIOTICS. ALL THE FOUR PATIENTS WERE REPORTED AS RECOVERED AFTER THESE EVENTS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS. THIS REPORT CAPTURES THE PATIENT THAT EXPERIENCED SEPSIS AND WAS RECEIVED ON INTENSIVE CARE UNIT (ICU).

  Patient problems: Sepsis

  MAUDE report 19913627 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE WATER VAPOR THERMAL THERAPY PROCEDURE FOUR PATIENTS EXPERIENCED AN INFECTION, ONE OF THE PATIENTS DEVELOPED SEPSIS SEVERAL DAYS AFTER THE INDWELLING CATHETER WAS REMOVED, THEREFORE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), TWO PATIENTS WERE ADMITTED TO HOSPITAL WITH SEVERE INFECTION AND WERE TREATED WITH INTRAVENOUS ANTIBIOTICS, THE LAST PATIENT REQUIRED ORAL ANTIBIOTICS. ALL THE FOUR PATIENTS WERE REPORTED AS RECOVERED AFTER THESE EVENTS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS. THIS REPORT CAPTURES THE PATIENT THAT REQUIRED ORAL ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 19913626 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE WATER VAPOR THERMAL THERAPY PROCEDURE FOUR PATIENTS EXPERIENCED AN INFECTION, ONE OF THE PATIENTS DEVELOPED SEPSIS SEVERAL DAYS AFTER THE INDWELLING CATHETER WAS REMOVED, THEREFORE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), TWO PATIENTS WERE ADMITTED TO HOSPITAL WITH SEVERE INFECTION AND WERE TREATED WITH INTRAVENOUS ANTIBIOTICS, THE LAST PATIENT REQUIRED ORAL ANTIBIOTICS. ALL THE FOUR PATIENTS WERE REPORTED AS RECOVERED AFTER THESE EVENTS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS. THIS REPORT CAPTURES ONE OF PATIENTS THAT EXPERIENCED A SERIOUS INFECTION AND WENT TO HOSPITAL WHERE WAS TREATED WITH INTRAVENOUS ANTIBIOTICS (IV AB'S).

  Patient problems: Unspecified Infection

  MAUDE report 19913623 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE WATER VAPOR THERMAL THERAPY PROCEDURE FOUR PATIENTS EXPERIENCED AN INFECTION, ONE OF THE PATIENTS DEVELOPED SEPSIS SEVERAL DAYS AFTER THE INDWELLING CATHETER WAS REMOVED, THEREFORE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), TWO PATIENTS WERE ADMITTED TO HOSPITAL WITH SEVERE INFECTION AND WERE TREATED WITH INTRAVENOUS ANTIBIOTICS, THE LAST PATIENT REQUIRED ORAL ANTIBIOTICS. ALL THE FOUR PATIENTS WERE REPORTED AS RECOVERED AFTER THESE EVENTS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS. THIS REPORT CAPTURES ONE OF PATIENTS THAT EXPERIENCED A SERIOUS INFECTION AND WENT TO HOSPITAL WHERE WAS TREATED WITH INTRAVENOUS ANTIBIOTICS (IV AB'S).

  Patient problems: Unspecified Infection

  MAUDE report 19913621 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT A PROCEDURE WITH THIS DELIVERY DEVICE. AFTER THE PROCEDURE, THE PATIENT WAS DISCHARGED WITH A CATHETER. SEVEN (7) DAYS LATER, THE PATIENT CAME BACK TO THE HOSPITAL TO HAVE THE CATHETER REMOVED AND WAS DISCHARGED ONCE AGAIN. THE NEXT DAY, THE PATIENT WENT TO THE HOSPITAL AND WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO SEPSIS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Sepsis

  MAUDE report 19576408 ↗
• InjuryJun 20, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE WITH THIS DEVICE, THE DELIVERY DEVICE FAILED TO RETRACT COMPLETELY. THE DELIVERY DEVICE WAS REMOVED, BUT THE PATIENT WAS UNDER DURESS AND WOULD NOT CONSENT FOR THE REQUIRED ADDITIONAL TREATMENT. IT WAS NOTED THAT MANUAL RETRACTION WAS TRIED, HOWEVER, THE INSTRUCTIONS TO DO IT WERE UNCLEAR, CAUSING AT THE END ABRASION IN THE URETHRA AS THE DEVICE WAS RETRACTED. THE PATIENT EXPERIENCED A HEMATOMA DUE TO THIS AND IN ADDITION THE PATIENT WAS INSTRUCTED TO DRINK ADDITIONAL WATER TO CLEAR THE BLOOD AND TO LEAVE THE CATHETER IN PLACED UNTIL A FOLLOW UP IN 4 WEEKS. THE PROCEDURE WAS ABORTED EARLY, AND THE PATIENT WILL NEED A SECOND THERAPY. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Hematoma; Pain

  MAUDE report 19575317 ↗