VersaPulse PowerSuite VersaPulse PowerSuite 100W (REF 0638-803-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07290109146195), received between Sep 7, 2022 and Sep 29, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Output below Specifications

  It was reported that the console had low energy. There was no error code message. There is no information whether a procedure was performed, or if there was patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927867 ↗
• MalfunctionSep 21, 2026Communication or Transmission Problem; Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847391 ↗
• MalfunctionSep 17, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812534 ↗
• MalfunctionJan 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONSOLE WAS LEAKING COOLANT. LOW POWER WAS ALSO NOTICED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045241 ↗
• MalfunctionJan 6, 2026Output below Specifications

  IT WAS REPORTED THAT THE DEVICE CUTTING EFFICIENCY WAS LOW AND THAT THERE WAS AN ENERGY DELIVERY OUTPUT/FAILURE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982133 ↗
• MalfunctionOct 29, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE DID NOT DELIVER SUFFICIENT POWER. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418198 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Smoking; Nonstandard Device; Smoking

  IT WAS REPORTED THAT THERE WAS A FIRE SMELL COMING FROM THE LASER WHILE IT WAS IN STORAGE. THE LAST TIME THE CONSOLE HAD BEEN USED WAS 4 DAYS PRIOR TO THE SMELL BEING NOTICED. THE CONSOLE IS NOT IN USE AND HAS NOT BEEN TURNED ON DUE TO THE SMELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303787 ↗
• MalfunctionSep 29, 2025Output below Specifications; Power Problem; Output below Specifications; Power Problem

  IT WAS REPORTED THAT THIS DEVICE REQUEST TO BE SERVICE DUE TO MESSAGE - REDUCED POWER, MAX POWER REDUCED TO 25 HZ 30W. THERE WERE NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23176026 ↗
• MalfunctionSep 26, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO ACHIEVE 100 WATTS OF ENERGY. IT WAS NOTED THAT THE DEVICE HAS AN ENERGY DEVICE DELIVERY OUTPUT FAILURE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23155925 ↗
• MalfunctionAug 29, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAD A LOW POWER OUTPUT AND THERE WERE NO ERRORS. HOWEVER, THE CONSOLE WAS WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926512 ↗
• MalfunctionMay 8, 2025Energy Output Problem; Device Displays Incorrect Message; Energy Output Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE INDICATED THAT THERE WAS A FAULT AND WAS NOT WORKING CORRECTLY AFTER 2 MINUTES OF THE LASER BLADDER NECK RESECTION PROCEDURE. THE BLADDER NECK TISSUE COULD NOT BE RESECTED PROPERLY. 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 21989443 ↗
• MalfunctionFeb 24, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT LASER ENERGY OUTPUT IS WEAK AND THAT A POWER BRICK MAY NEED REPLACEMENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING PROCEDURE OR PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446362 ↗
• MalfunctionJan 23, 2025Power Conditioning Problem; Smoking; Power Conditioning Problem; Smoking

  IT WAS REPORTED THAT DURING DAILY INSPECTION, WHEN THE DEVICE WAS TURNED ON, THE CIRCUIT BREAKER WAS FOUND TO BE TRIPPED, AND A BURNT SMELL WAS NOTED. THE FUSE WAS FOUND TO BE BLOWN. THE DEVICE OPERATED NORMALLY AFTER REPEATED POWER CYCLE. THE FUSE WAS REINSTALLED AND SECURED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219782 ↗
• MalfunctionJan 22, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE HAD AN INSUFFICIENT POWER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, THERE WERE NO PATIENT COMPLICATIONS REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207942 ↗
• MalfunctionDec 4, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WERE SPARKS IN THE CAVITY OF THE DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845556 ↗
• MalfunctionOct 9, 2024Adverse Event Without Identified Device or Use Problem; Output below Specifications; Adverse Event Without Identified Device or Use Problem; Output below Specifications

  IT WAS REPORTED THAT THIS DEVICE WOULD NOT REACH ENOUGH ENERGY DURING A PROCEDURE. NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412276 ↗
• MalfunctionJan 7, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CONSOLE DISPLAYED CASE SAVER MODE AND ENTERED IN LOWER POWER SETTING, SO THE PROCEDURE WAS CANCELLED. THE PATIENT WAS STABLE UNDER GENERAL ANESTHESIA, THERE WAS NO PATIENT COMPLICATION. AFTER THAT, THE COMPANY REPRESENTATIVE INFORMED THAT THE MACHINE WAS USABLE FOR VERY SMALL STONES AT LOW POWER, SO WE WERE ABLE TO COMPLETE THE NEXT CASE WITHOUT ANY ISSUES. 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 18461613 ↗
• MalfunctionJan 7, 2024Failure to Power Up; Unintended Application Program Shut Down; Failure to Power Up; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING A BLADDER STONE PROCEDURE, THE CONSOLE SHUT DOWN COMPLETELY. IT WAS RESTARTED, TURNED KEY SWITCH AND MAKES SOUNDS LIKE IT WANTS TO POWER ON BUT WON NOT. PATIENT WAS STABLE UNDER GENERAL ANESTHESIA, 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 18461583 ↗
• MalfunctionAug 18, 2023Defective Device; Material Integrity Problem; Output below Specifications; Defective Device; Material Integrity Problem; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE IS IN CASE SAVER MODE, HAS A BROKEN KEY SWITCH AND A DAMAGED INTERLOCK. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571657 ↗
• MalfunctionJul 5, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE FOOT PEDAL CORD FRAYED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 17257611 ↗
• MalfunctionJun 28, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT WHEN THE FOOTSWITCH WAS PRESSED, A HIGH ENERGY ERROR MESSAGE OCCURRED. THE LASER WENT FROM READY STATE TO FAULT. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PROCEDURE WAS CANCELLED WITH THE PATIENT UNDER GENERAL ANESTHESIA. 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 17221898 ↗
• MalfunctionJun 26, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PREPARATION, THE CONSOLE KEY SWITCH WAS SPINNING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT COMPLICATION. 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 17199523 ↗
• MalfunctionSep 8, 2022Smoking; Smoking

  IT WAS REPORTED THAT THE SYSTEM WAS STILL PRODUCING A BURNING SMELL AT A SECOND CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382904 ↗
• MalfunctionSep 7, 2022Smoking; Smoking

  IT WAS REPORTED THAT THE SYSTEM HAD A BURNING SMELL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369922 ↗