AquaBeam Robotic SystemRecalls & reported problems across all models

We found 3 models of AquaBeam Robotic System by PROCEPT BioRobotics Corporation in the FDA's device registry (GUDID). Together they are named in 944 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2019 and Sep 30, 2026 — classified as 26 deaths, 463 injuries, 455 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (188 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 AquaBeam Robotic System problems

AquaBeam Robotic System models

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

• AquaBeam Robotic System AB2000

  Fluid jet removal system
  21 deaths827 reports
• AquaBeam Robotic System AB2000

  Fluid jet removal system
  5 deaths101 reports
• AquaBeam Robotic System AB2000C

  Fluid jet removal system
  16 reports

Recent AquaBeam Robotic System adverse event reports

The 15 most recent reports across all models, 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 28, 2026Infusion or Flow Problem

  A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics Corporation (PROCEPT) became aware that the patient developed sepsis, requiring medical intervention. It was reported that during the second treatment pass of Aquablation, the aspiration tube became clogged on the AQUABEAM Handpiece, and the surgeon elected to convert the procedure to transurethral resection of the prostate (TURP). Additional information obtained indicated that the patient's bladder wall was injured during the Aquablation procedure, but no perforation was observed. As a result of the sepsis, the patient was transferred to the intensive care unit (ICU) for treatment, then transferred to the urology ward, and eventually recovered. The exact cause of the sepsis remains unknown.

  Patient problems: Laceration(s); Septic Shock

  MAUDE report 50489097 ↗
• 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 ↗
• InjuryJul 31, 2026Computer Software Problem

  A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics Corporation became aware that, post-Aquablation therapy, during Focal Bladder Neck Cautery (FBNC), it appeared that no butterfly cut was performed even though the treating surgeon adequately planned the treatment on the Aquabeam Robotic System. The system indicated a right apical cut followed by a left apical cut, but the butterfly cut could not be visualized on the cystoscope, indicating that the patient's veru-protection zone was ablated with the waterjet. The patient did not receive any additional medical intervention.

  Patient problems: Sexual Dysfunction

  MAUDE report 50099888 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH) on (b)(6) 2026. PROCEPT BioRobotics became aware on (b)(6) 2026 that the patient sustained a slight bladder perforation. The patient had a catheter in place before Aquablation therapy and a pre-existing diverticulum. It was also noted that the patient had lots of calcifications that potentially distorted the ultrasound image, and cautery took an extended time due to an erection and leftover apical tissue. The patient was then sent home, but later fell ill, and a CT scan revealed leakage in the bladder. The treating surgeon is unsure of the origin of the leakage and has no other information. No additional surgery or medical intervention was required. No malfunction of the AQUABEAM Robotic System was reported.

  Patient problems: Perforation

  MAUDE report 50098621 ↗
• 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 27, 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 CONTROL 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 24999725 ↗

Other PROCEPT BioRobotics Corporation products

• AquaBeam Handpiece5 models · 22 reports