AquaBeam Robotic System AB2000 (UDI B614AB20001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 827 adverse event reports that list this exact device (DI B614AB20001), received between Oct 31, 2019 and Sep 30, 2026 — classified as 21 deaths, 389 injuries, 417 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (161 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 827 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics Corporation (PROCEPT) became aware that, during Focal Bladder Neck Cautery (FBNC), the patient sustained a bladder perforation. The treating surgeon indicated that the bladder perforation likely occurred during hemostasis at a thin-walled portion of the diverticulum. The bladder was repaired laparoscopically. No malfunction of the AQUABEAM Robotic System was reported.

  Patient problems: Perforation

  MAUDE report 50950626 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation

  MAUDE report 50926025 ↗
• MalfunctionSep 22, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859574 ↗
• MalfunctionSep 2, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568871 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  A male patient underwent Aquablation therapy for symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics (PROCEPT) became aware that, during Focal Bladder Neck Cautery (FBNC), the patient's left ureteral orifice was roughened. The surgeon placed a stent as a safety precaution and plans to remove it in 6 weeks. No additional surgeries/interventions were required. No malfunction of the AQUABEAM Robotic System was reported.

  Patient problems: Perforation

  MAUDE report 50178180 ↗
• MalfunctionJul 31, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50103783 ↗
• DeathMay 20, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT EXPERIENCED CARDIAC ARREST, FOLLOWED BY DEATH. THE CAUSE OF DEATH REMAINS UNKNOWN, AS THE TREATING SURGEON DID NOT PROVIDE ANY FURTHER DETAILS DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION SUCH AS THE CAUSE OF DEATH AND THE RELATIONSHIP TO THE DEVICE OR PROCEDURE. THE DATE OF DEATH IS ALSO UNKNOWN. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 25232235 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT WAS BLEEDING AND WAS TAKEN BACK INTO THE OPERATING ROOM FOR CAUTERIZATION TO ACHIEVE HEMOSTASIS. THE PATIENT HAS BEEN DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25153865 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) TO CONTROL BLEEDING. THE PATIENT REQUIRED A BLOOD TRANSFUSION. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25153791 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR BLEEDING AND ADDRESSED VIA CAUTERY AND CLOT EVACUATION. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25033338 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS BECAME AWARE THAT, TWO (2) DAYS POST AQUABLATION THERAPY, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH AN INTRAPERITONEAL BLADDER PERFORATION. THE BLADDER WAS REPAIRED BY ANOTHER ON-CALL SURGEON, AND THE PATIENT HAS SINCE BEEN DISCHARGED. IT WAS REPORTED THAT THE CAUSE OF THE INTRAPERITONEAL BLADDER PERFORATION IS UNKNOWN. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 25033282 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, FOLLOWING AQUABLATION THERAPY, THE PATIENT WAS BLEEDING AND REQUIRED RETURN TO THE OPERATING ROOM FOR CLOT EVACUATION. THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24851904 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING FOCAL BLADDER NECK CAUTERY, IT WAS REPORTED THAT THE PATIENT'S RIGHT URETERAL ORIFICE (UO) WAS OBSERVED TO BE DAMAGED. PATIENT'S LEFT UO WAS UNAFFECTED. AS A RESULT, THE TREATING SURGEON PLACED A URETERAL STENT IN THE PATIENT'S RIGHT URETERAL ORIFICE. DESPITE REPEATED EFFORTS TO OBTAIN AN UPDATE, THE PATIENT¿S CURRENT STATUS REMAINS UNKNOWN AS NO INFORMATION HAS BEEN PROVIDED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24810728 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST AQUABLATION THERAPY, THE SURGEON INSERTED THE CATHETER INTO A FALSE PASSAGE IN THE URETHRA MULTIPLE TIMES. THE COMBINATION OF THE PROCEDURAL DELAY AND THE INSERTION OF THE CATHETER INTO THE FALSE PASSAGE CAUSED THE PATIENT TO BLEED, REQUIRING A BLOOD TRANSFUSION. THE PATIENT HAS SINCE BEEN DISCHARGED AND IS DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24769856 ↗
• MalfunctionApr 1, 2026Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING INITIAL SETUP AND WHILE THE PATIENT WAS IN THE OPERATING ROOM (OR) UNDER ANESTHESIA, THE AQUABEAM HANDPIECE GENERATED AN E03 - CONSOLE ERROR CODE. TROUBLESHOOTING WAS PERFORMED; HOWEVER, THE ISSUE PERSISTED. TWO ADDITIONAL AQUABEAM HANDPIECES WERE USED, BUT THE SAME ERROR OCCURRED AGAIN. THE SURGEON ELECTED TO ABORT THE PROCEDURE AND RESCHEDULE FOR A LATER DATE. THE PATIENT EXPERIENCED NO ADVERSE HEALTH EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760717 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT THE PATIENT HAD ABDOMINAL DISTENSION FOLLOWING AQUABLATION THERAPY. IT WAS FOUND THAT THE PATIENT HAD AN INTRAPERITONEAL BLADDER RUPTURE. THE TEAR WAS SEVERAL CENTIMETERS IN SIZE, WHICH WOULD NOT POINT TO AN INSTRUMENT PERFORATION BUT RATHER TO A PRESSURE-INDUCED PERFORATION. AS PER THE TREATING SURGEON, THE POTENTIAL ROOT CAUSE OF THIS EVENT IS A WEAK SPOT IN THE BLADDER AND PRESSURE FROM THE PRESSURE-REGULATING DEVICE (ELLIK BLADDER EVACUATOR). THE BLADDER WAS REPAIRED LAPAROSCOPICALLY. THE PATIENT HAS SINCE BEEN DISCHARGED AND IS DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24716678 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT WAS BLEEDING AND TAKEN BACK INTO THE OPERATING ROOM FOR CAUTERIZATION TO ACHIEVE HEMOSTASIS. THE PATIENT'S CATHETER WAS REMOVED AT 24 HOURS. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24699132 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING POST-FOCAL BLADDER NECK CAUTERY AND PRIOR TO DISCHARGE, THE PATIENT STRUGGLED TO ACHIEVE HEMOSTASIS. THE SURGEON INITIALLY MANAGED THE PATIENT'S BLEEDING WITH TRACTION AND CONTINUOUS BLADDER IRRIGATION (CBI). WHILE THE PATIENT WAS IN THE POST-ANESTHESIA CARE UNIT (PACU), THE SURGEON ORDERED 1G OF TRANEXAMIC ACID (TXA) TO HELP CONTROL THE BLEEDING. THE PATIENT'S HEMOGLOBIN LEVEL DROPPED TO 5.2 G/DL, NECESSITATING A BLOOD TRANSFUSION. AFTER THE TRANSFUSION, THE PATIENT'S HEMOGLOBIN LEVELS RETURNED TO NORMAL. PATIENT IS WELL AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24662442 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT RETURNED TO THE OPERATING ROOM FOR ADDITIONAL CAUTERY TO ADDRESS BLEEDING. THE PATIENT HAS SINCE RECOVERED AND BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24496162 ↗
• MalfunctionFeb 26, 2026Connection Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT WHILE THE CUSTOMER WAS SETTING UP, THE ULTRASOUND IMAGE DID NOT APPEAR ON THE CPU, AND THERE WAS NO TRUS SIGNAL. THE CUSTOMER ATTEMPTED TO RESEAT THE CABLE CONNECTION, POWER-CYCLE THE SYSTEM, AND SWAP THE TRUS PROBE, BUT THE ISSUE PERSISTED. AS A RESULT OF THIS ISSUE, THE PROCEDURE WAS CONVERTED TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455490 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT THE PATIENT SUSTAINED A BLADDER PERFORATION. DUE TO A TIGHT URETHRA AND A HIGH BLADDER NECK, THE TREATING SURGEON SLIGHTLY LOWERED THE TRUS PROBE TO ALLOW ENTRY OF THE AQUABEAM HANDPIECE. THIS INADVERTENTLY CAUSED THE AQUABEAM HANDPIECE TO ADVANCE DIRECTLY THROUGH THE BLADDER WALL, RESULTING IN THE PERFORATION. A URINARY CATHETER WAS INSERTED, AND THE TREATING SURGEON NOTED THAT THE PERFORATION WOULD HEAL WITH CONSERVATIVE MANAGEMENT. NO INTERVENTIONS OR SURGERIES WERE PERFORMED, AND THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24388759 ↗
• DeathFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT AFTER AQUABLATION THERAPY AND DURING FOCAL BLADDER NECK CAUTERY, THE PATIENT CODED. IT WAS REPORTED THAT MASSIVE CLOTS WERE FOUND IN BOTH THE LEFT AND RIGHT ATRIA. THE PATIENT HAS A HISTORY OF ATRIAL FIBRILLATION (AFIB) AND STOPPED TAKING ANTICOAGULANT MEDICATION (ELIQUIS) 3 DAYS PRIOR TO THE PROCEDURE. ACCORDING TO THE TREATING SURGEON, THE CLOTS WERE IDENTIFIED AS NEW AND LIKELY FORMED WITHIN THE LAST 3 DAYS OF THE PROCEDURE. THE PATIENT WAS TAKEN TO THE CORONARY CARE UNIT (CCU) TO HAVE THE CLOTS IN THE ATRIUM EVACUATED AND REMAINED STABLE. IT WAS REPORTED THAT THE PATIENT PASSED AWAY A FEW DAYS POST-AQUABLATION THERAPY. NO OTHER DETAILS WERE PROVIDED REGARDING THE PATIENT'S DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. PROCEPT HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL DETAILS REGARDING THE PATIENT'S DEATH; HOWEVER, TO DATE, NO ADDITIONAL DETAILS HAVE BEEN RECEIVED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 24308468 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION WAS INFORMED THAT DURING THE AQUABLATION THERAPY, THE SURGEON IDENTIFIED A BLADDER DIVERTICULUM AND A SIGNIFICANTLY HIGH MEDIAN LOBE OF THE PROSTATE. AS THE HANDPIECE WAS ADVANCED INTO THE PATIENT, THE SURGEON, NOT RECOGNIZING THE RESISTANCE, PUSHED THE TIP OF THE HANDPIECE THROUGH THE BLADDER WALL. THE BLADDER PERFORATION WAS IMMEDIATELY IDENTIFIED BY THE TREATING SURGEON AND WAS REPAIRED WITH DIATHERMY. THE TREATING SURGEON ELECTED TO ABORT THE PROCEDURE AND WAIT UNTIL THE PATIENT'S BLADDER HEALS TO PERFORM AQUABLATION. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS DISCHARGED THE NEXT DAY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24282592 ↗
• InjuryFeb 6, 2026Insufficient Device Problem Information

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT A PATIENT EXPERIENCED CONTINUED HEMATURIA AND HAD TO BE TAKEN BACK ON TWO (2) SEPARATE OCCASIONS AND REQUIRED ADDITIONAL CONTINUOUS BLADDER IRRIGATION (CBI) FOR APPROXIMATELY ONE (1) WEEK DURING THE HOSPITAL STAY PRIOR TO DISCHARGE. NO FURTHER DETAILS HAVE BEEN PROVIDED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24282381 ↗
• DeathJan 28, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, INTRAOPERATIVELY, IMAGING OF THE BLADDER AND BLADDER NECK WAS CHALLENGING DUE TO PATIENT ANATOMY. DURING FOCAL BLADDER NECK CAUTERY, THE BLADDER WAS DISRUPTED BY THE WATERJET BUT NOT PERFORATED. CAUTERY WAS APPLIED, BOTH URETERAL ORIFICES WERE IDENTIFIED, THE LEFT URETERAL ORIFICE WAS UNAFFECTED, AND THE RIGHT URETERAL ORIFICE WAS CONTACTED BY THE WATERJET BUT NOT OCCLUDED, AND NO STENT WAS PLACED. AS PER THE TREATING SURGEON, THERE WAS NO INJURY TO THE BLADDER OR URETERAL ORIFICES. POSTOPERATIVELY, THE PATIENT EXPERIENCED UNRELATED MEDICAL ISSUES ASSOCIATED WITH POOR BASELINE HEALTH, INCLUDING ATRIAL FIBRILLATION, AND THE TREATING SURGEON BELIEVED THAT CONTINUOUS BLADDER IRRIGATION (CBI) INTERRUPTION DURING POSTOPERATIVE TRANSFERS LED TO CLOT FORMATION REQUIRING CLOT EVACUATION. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR ADDITIONAL CAUTERY TO OBTAIN HEMOSTASIS. FOLLOW-UP INFORMATION CONFIRMED THE PATIENT WAS DISCHARGED AND LATER DECEASED, WITH THE TREATING SURGEON ATTRIBUTING THE DEATH TO PRE-EXISTING POOR HEALTH AND CARDIAC ISSU

  Patient problems: Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24205792 ↗