GreenLight XPSRecalls & reported problems across all models
Boston Scientific Corporation · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of GreenLight XPS by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2023 and Sep 18, 2026 — classified as 1 injury, 20 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (11 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
Reports received per month, all models
Most reported GreenLight XPS problems
Device problems
- Device Displays Incorrect Message11
- Power Problem4
- Smoking4
- Failure to Power Up3
- No Display/Image3
- Nonstandard Device3
- Defective Device2
- Electrical /Electronic Property Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Hemorrhage/Blood Loss/Bleeding1
- Scar Tissue1
GreenLight XPS models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GreenLight XPS™ 0010-0210S-G0Powered laser surgical instrument15 reports
- GreenLight XPS™ 0010-0210S-GZ0Powered laser surgical instrument6 reports
Recent GreenLight XPS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828847 ↗MalfunctionApr 23, 2026Nonstandard Device; Failure to Power Up; Power Problem; Unexpected Shutdown
IT WAS REPORTED THAT DURING PROCEDURE, THE CONSOLE DISPLAYED ERROR CODE 213 (LASER POWER SUPPLY OFF SETPOINT) AFTER 30 MINUTES OF USE. WHEN "CLEAR PROBLEM" WAS PRESSED, THE POWER SHUT OFF AND THE CONSOLE WOULD NOT START UP AFTERWARD. RESTARTING FROM THE BREAKER DID NOT CHANGE THE SITUATION. THERE WAS A SLIGHT UNUSUAL ODOR WAS ALSO NOTED. THE PROCEDURE WAS COMPLETE USING A NON BSC PRODUCT. THERE WERE NO PATIENT COMPLICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND SERVICED THE CONSOLE AT THE FACILITY. DURING EVALUATION OF THE CONSOLE, A BURNING SMELL WAS DETECTED; THEREFORE, REPORTABILITY CRITERIA IS MET BASED ON THIS FINDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974810 ↗MalfunctionMar 16, 2026Power Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE DISPLAYED ERRORS 211 (LASER POWER SUPPLY BRICK FAULT) AND 213 (LPS OFF SETPOINT). THE CONSOLE POWERED OFF AND DID NOT TURN POWER ON AGAIN. DUE TO THIS, THE PROCEDURE COULD NOT BE COMPLETED WHEN THE PATIENT WAS UNDER GENERAL SEDATION. 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 24614113 ↗MalfunctionDec 12, 2025Smoking; Power Problem; Unexpected Shutdown; Smoking; Power Problem; Unexpected Shutdown
IT WAS REPORTED THAT DURING A PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE CONSOLE SHUTDOWN AND THE ERROR CODES 210-LASER POWER SUPPLY AND 211-LASER POWER SUPPLY BRICK FAULT WERE DISPLAYED. AFTER SHUTTING DOWN, IT DID NOT START EVEN WHEN THE POWER WAS TURNED BACK ON. WHEN THE POWER CORD WAS UNPLUGGED AND LEFT FOR A WHILE BEFORE RESTARTING, SMOKE WAS EMITTED, POSSIBLY DUE TO SOMETHING BURNING INSIDE. THE PROCEDURE WAS COMPLETED WITH TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) WITHOUT PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791133 ↗MalfunctionSep 22, 2025No Display/Image; Smoking; No Display/Image; Smoking
IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE LASER WAS POWERED ON, THE DISPLAY SCREEN WAS BLACK AND BURNING SMELL WAS COMING OUT OF LASER. ANOTHER DEVICE OF DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23110948 ↗MalfunctionJun 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING PREPARATION PRIOR TO PROCEDURE, THE COAGULATION PEDAL REMAINED ACTIVATED, IT APPEARS THAT THE CONTACT IS DAMAGED. THE PROCEDURE WAS COMPLETED USING THE SAME GENERATOR WITH A DIFFERENT FOOT SWITCH WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22308263 ↗MalfunctionJun 6, 2025Insufficient Cooling; Electrical /Electronic Property Problem; Nonstandard Device; Defective Device; Device Displays Incorrect Message; Insufficient Cooling; Electrical /Electronic Property Problem; Nonstandard Device; Defective Device; Device Displays Incorrect Message
IT WAS REPORTED THAT PRIOR THE PVP (PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE) PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE CONSOLE IS STUCK DISPLAYING, PLEASE WAIT. IT WAS NOTED THE CONSOLE DISPLAYED ERROR 302.13 (MCB. HARDWARE INTERLOCK BIT) AND ERROR 632 (WARMUP TIMEOUT). THE PROCEDURE WAS DISCONTINUED. 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 22160067 ↗MalfunctionMay 15, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT THE CONSOLE DISPLAYED ERROR CODE 660 DURING PROCEDURE. THE CONSOLE WAS TURNED OFF FOR SAFETY AND THEN ERROR CODED 611 AND 831 WERE DISPLAYED, THEREFORE, THE DAY WAS SUSPENDED. THERE WAS NO PROCEDURE AND PATIENT OUTCOME REPORTED. A FULL SERVICE WAS PERFORMED ON THE CONSOLE; HOWEVER NO ISSUES WERE OBSERVED DURING THE EVALUATION. ALSO, WAS INFORMED THAT THE CITY WHERE THE EQUIPMENT IS LOCATED HAS BEEN EXPERIENCING ISSUES WITH THE ELECTRICAL GRID, AND THAT ELECTRICAL IRREGULARITIES MAY BE CONTRIBUTING TO THE REPORTED ERRORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22032100 ↗MalfunctionMar 19, 2025Defective Device; Defective Device
IT WAS REPORTED THAT DURING A PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE CONSOLE DID NOT PROCEED FROM PLEASE WAIT, THEREFORE, THE DEVICE COULD NOT BE USED. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE PROCEDURE WAS NOT COMPLETED DUE TO REPORTED ISSUE. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21646740 ↗MalfunctionFeb 25, 2025Failure to Power Up; Device Displays Incorrect Message; Failure to Power Up; Device Displays Incorrect Message
IT WAS REPORTED THAT THE DEVICE DOES NOT START UP, AND ERRORS 630, 302.13, 202.11 AND 710 DISPLAYED. THE ERRORS CLEARED, BUT ERROR 630 SHOWED AGAIN. THE CONSOLE WAS RESTARTED AFTER REFILLING PURIFIED WATER, BUT THE PROBLEM PERSISTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458199 ↗MalfunctionAug 1, 2024Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING PROCEDURE THE CONSOLE DISPLAYED ERROR CODES 211, 213 AND 825. THE PROCEDURE WAS NOT COMPLETED. 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 19888188 ↗MalfunctionJul 10, 2024Insufficient Cooling; Electrical /Electronic Property Problem; Nonstandard Device; Use of Device Problem; Device Displays Incorrect Message; Power Problem; Insufficient Cooling; Electrical /Electronic Property Problem; Nonstandard Device; Use of Device Problem; Device Displays Incorrect Message; Power Problem
IT WAS REPORTED THAT PRIOR TO A PHOTO SELECTIVE VAPORIZATION PROCEDURE FOR BLADDER STONE, THE CONSOLE WAS STARTED, BUT THEN THE DEVICE WAS TURNED OFF IN ORDER TO SWITCH THE POWER SUPPLY. AFTER THAT THE CONSOLE DID NOT START UP AND IT DISPLAYED ERROR CODES 641, 302.13, AND 202.11. THE CONSOLE WAS REBOOTED, BUT THE ERROR CODES DID NOT CLEAR. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, THE PROCEDURE WAS CANCELLED. 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 19711205 ↗InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE 111TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION JOURNAL THAT A STUDY WAS CONDUCTED TO EXAMINE THE EFFECTIVENESS AND SAFETY OF PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE AFTER EXPERIENCING 100 CASES SINCE ITS INTRODUCTION. BETWEEN JULY 2022 TO AUGUST 2023, A TOTAL OF 100 PATIENTS DIAGNOSED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) WERE INCLUDED IN THIS STUDY. FIVE PATIENTS HAD A HISTORY OF URINARY RETENTION, AND FOUR OF THEM HAD AN INDWELLING URINARY CATHETER OR SELF-CATHETERIZED AT THE TIME OF SURGERY. IT WAS OBSERVED THAT THERE WAS POSTOPERATIVE SERUM HEMOGLOBIN CONCENTRATION DECREASE. THERE WERE TWO CASES OF REOPERATION FOR BLADDER NECK SCLEROSIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Scar Tissue
MAUDE report 19702664 ↗MalfunctionMay 21, 2024Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT PRIOR TO A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, A MESSAGE INDICATING THE FIBER EXPIRED WAS DISPLAYED. THE FIBER WAS CHANGED BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CANCELLED OR RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS. IT WAS NOTED THAT THE TECHNICIAN WENT ONSITE AFTERWARDS, AND FOUND IT IS NORMAL FOR THE MACHINE TO TIME OUT AFTER 30 MINUTES OF INACTIVITY. THIS EVENT IS BEING REPORTED FOR CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356554 ↗MalfunctionMar 26, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT, DURING PREPARATION FOR THE PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE SCREEN DID NOT DISPLAY ANY IMAGES. THE PROCEDURE WAS THEN CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18981212 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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