rezum GeneratorRecalls & reported problems across all models

We found 5 models of rezum Generator by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2019 and Aug 14, 2026 — classified as 1 death, 10 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (17 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 Generator problems

rezum Generator models

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

• rezum Generator G2200

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 death24 reports
• rezum Generator G2200-003D

  Unit, electrosurgical, endoscopic (with or without accessories)
  17 reports
• rezum Generator G2200-003R

  Unit, electrosurgical, endoscopic (with or without accessories)
  15 reports
• rezum Generator G2200-003Z

  Unit, electrosurgical, endoscopic (with or without accessories)
  8 reports
• rezum Generator G2200-003H

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

Recent rezum Generator adverse event reports

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

• MalfunctionAug 14, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260525 ↗
• MalfunctionJun 30, 2026No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHYSICIAN EXPERIENCED ISSUES WITH THE GENERATOR DURING FOUR PROCEDURES. IT REPEATEDLY DISPLAYED ALERT MESSAGES AND THE SCREEN WENT BLANK. THREE BENIGN PROSTATIC HYPERPLASIA CASES WERE COMPLETED, BUT PROCEDURE TIMES WERE PROLONGED DUE TO THE DEVICE MALFUNCTION. THE FOURTH CASE WAS ABORTED. THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673548 ↗
• MalfunctionJun 29, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE, THE DELIVERY DEVICE DID NOT PRODUCE STEAM WHEN CONNECTED TO THE GENERATOR. IT WAS NOTED THAT THE GENERATOR WAS RESTARTED AND THE CONNECTION WAS CHECKED; HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661388 ↗
• MalfunctionApr 6, 2026No Display/Image; Mechanical Problem

  IT WAS REPORTED THAT, DURING PROCEDURE, UPON CONNECTING THE GRAY CABLE OF THE DELIVERY DEVICE, THE SCREEN BLACKED OUT. AFTER REBOOTING, A 275 (SYRINGE WATER FILL ERROR) ERROR OCCURRED, MAKING THE DEVICE UNUSABLE. EVEN AFTER REPLACING THE DELIVERY DEVICE WITH THREE DIFFERENT CABLES, THE SITUATION REMAINED UNCHANGED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795473 ↗
• MalfunctionDec 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A TRANSURETHRAL PROSTATE STEAM TREATMENT PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, WHILE PRIMMING, THERE WAS NO STEAM WAS EMITTED AT ALL. FURTHERMORE, STEAM SHOULD HAVE BEEN EMITTED FROM THREE DIRECTIONS, YET NONE CAME OUT BUT LATER, THE DEVICE DISPLAYED THE PRIMING COMPLETE SCREEN. AN EXTERNAL NEEDLE WAS EXTENDED, SIMILAR TO THE INTERNAL ONE, AND STEAM WAS SPRAYED, BUT NO STEAM WAS EMITTED. IT WAS ATTEMPTED TO USE FOUR DIFFERENT DELIVERY DEVICES, BUT THE ISSUE PERSISTED AND THE GENERATOR COULD NOT BE USED FOR TWO OPERATIONS. DUE TO THIS, THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN. THIS COMPLAINT IS FOR THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863081 ↗
• MalfunctionDec 15, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PROCEDURE, A LOW-TEMPERATURE ERROR PROMPTED, AND NO STEAM WAS EMITTED. THE ISSUE PERSISTED EVEN AFTER RESTARTING DEVICE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. ADDITIONAL INFORMATION NOTED THAT THE PATIENT WAS TEMPORARILY DISCHARGED AND IS SCHEDULED FOR A REOPERATION ON A DIFFERENT DATE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804982 ↗
• MalfunctionDec 2, 2025Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA PROCEDURE, THE ROLLER WAS NOT WORKING AND THERE WAS AN UNUSUAL NOISE AND ERROR CODE 455-SALINE PUMP SELF-TEST ERROR WAS DISPLAYED. THE CONSOLE WAS REBOOTED, BUT THE ERROR PERSISTED. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE PROCEDURE WAS POSTPONED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694937 ↗
• MalfunctionNov 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO THE WATER VAPOR THERAPY PROCEDURE, THE DELIVERY DEVICE COULD NOT WORK BECAUSE THE GENERATOR DISPLAYED ERROR 275 SYRINGE WATER FILL ERROR. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554883 ↗
• MalfunctionNov 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO THE WATER VAPOR THERAPY PROCEDURE, THE DELIVERY DEVICE COULD NOT WORK BECAUSE THE GENERATOR DISPLAYED ERROR 275 SYRINGE WATER FILL ERROR. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554636 ↗
• MalfunctionJul 31, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING A WATER VAPOR THERMAL THERAPY PROCEDURE, ERROR 495 WAS DISPLAYED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677376 ↗
• MalfunctionJul 28, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT, DURING A WATER VAPOR THERAPY PROCEDURE, ERROR 495 (RF POWER SUPPLY SELF-TEST ERROR) WAS DISPLAYED. IT WAS UNCLEAR WHETHER THE ERROR WAS CAUSED BY A PROBLEM WITH THE GENERATOR OR THE DELIVERY DEVICE. THE DELIVERY DEVICE WAS UNPACKED AND CONNECTED TO THE GENERATOR, BUT THE ISSUE PERSISTED, SO THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631671 ↗
• InjuryJul 22, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE WATER VAPOR THERMAL THERAPY PROCEDURE, NO STEAM WAS EMITTED DURING THE 8TH AND 9TH SHOTS. DURING THESE SHOTS, THE COUNTDOWN SOUND DID NOT PLAY, AND IT SEEMED TO BE IN STANDBY MODE. THE DEVICE WAS REMOVED ONCE, AND THE STEAM WAS ACTIVATED OUTSIDE THE BODY TO CONFIRM THAT IT WAS SPRAYING, THEN IT WAS REINSERTED, AND PUNCTURE WAS PERFORMED AGAIN, BUT IT STILL SEEMED THAT NO STEAM WAS EMITTED. BLEEDING FROM THE FINAL SHOT SITE DID NOT STOP AND EVENTUALLY REQUIRED HEMOSTASIS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THIS COMPLAINT REFERS TO THE GENERATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22566788 ↗
• MalfunctionMay 14, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT, PRIOR TO A PROCEDURE, THE CUSTOMER OBSERVED THAT THE IRRIGATION WAS NOT FLOWING. TROUBLESHOOTING WAS PERFORMED, AND IT WAS CONFIRMED THAT THE CUSTOMER WAS FOLLOWING THE STEPS CORRECTLY. HOWEVER, IRRIGATION STILL WOULD NOT FLOW THROUGH THE DEVICE. THEN, IT WAS FURTHER ATTEMPTED TO DEPLOY THE NEEDLE IN HOPES IRRIGATION WOULD AUTOMATICALLY FLOW, BUT IT DID NOT WORK. A SECOND DELIVERY DEVICE WAS USED AND HAD THE SAME IRRIGATION ISSUE. IT WAS NOTED THAT THIS IS LIKELY A ROLLER PUMP ISSUE WITH THE GENERATOR. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS ALREADY UNDER GENERAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022772 ↗
• MalfunctionMay 12, 2025Mechanical Problem; Nonstandard Device; Defective Device; Mechanical Problem; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION, THE DEVICE DISPLAYED AN ERROR CODE 275 (SYRINGE WATER FILL ERROR). IT WAS ALSO NOTED THAT, AFTER REPLACING THE DELIVERY DEVICE AND REBOOTING, THE SITUATION DID NOT CHANGE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS UNDER SPINAL ANESTHESIA AND THERE WAS NO REPORT OF PATIENT COMPLICATIONS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND PATIENT OUTCOME, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004518 ↗
• MalfunctionApr 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS AN IRRIGATION AND ROLLER PUMP ISSUE WITH THE SYSTEM, AS BEFORE TO THE PROCEDURE BEGINNING AND BEFORE INSERTING THE DEVICE INTO THE PATIENT, THE PHYSICIAN NOTICED THAT THE SALINE WAS NOT FLOWING. A DIFFERENT HANDPIECE WAS USED, BUT THE ISSUE PERSISTS. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911558 ↗

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