rezum Generator G2200-003ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729986874), received between Jul 28, 2023 and Aug 14, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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, 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 8 most recent of 8 reports, 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 ↗
• 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 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 ↗
• 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 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 ↗
• MalfunctionJan 2, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION, AFTER THE PATIENT WAS UNDER LUMBAR ANESTHESIA, THE ERROR 275 OCCURRED WHILE PRIMING. THE SETUP WAS REDONE, AND THE DELIVERY DEVICE WAS REPLACED, HOWEVER, THE EVENT PERSISTED AND GENERATOR ERROR 480 ALSO OCCURRED THEREAFTER. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE NEXT DAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430128 ↗
• MalfunctionJul 28, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING PREPARATION FOR THE PROCEDURE AND FOLLOWING PATIENT SEDATION, THE GENERATOR DID NOT PROGRESS FORWARD FROM THE WINDOWS SCREEN. REBOOTING THE GENERATOR DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS THEN CANCELLED. ANOTHER DEVICE WAS BROUGHT IN, AND THE PATIENT WAS SEDATED AGAIN. THE PROCEDURE WAS THEN COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414083 ↗