VersaPulse Powersuite VersaPulse Powersuite 80/100W (REF 0638-807-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07290109146225), received between Dec 13, 2022 and Feb 19, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Nonstandard Device; Smoking

  IT WAS REPORTED THAT THE DEBRIS SHIELD IS BURNT AND SMOKE WAS RISING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385436 ↗
• MalfunctionMay 30, 2025Smoking; Defective Device; Smoking; Defective Device

  IT WAS REPORTED THAT, THE BLAST SHIELD WAS BURNT AND BURNING SMELL WAS NOTICED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118485 ↗
• MalfunctionFeb 21, 2025Adverse 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 THE LASER OUTPUT WAS WEAK. THE CONSOLE DID NOT DISPLAY A COURTESY MESSAGE NOR ERROR CODE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437100 ↗
• MalfunctionAug 23, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A CASE, THE CONSOLE DISPLAYED ERROR 505 (VOLTAGE ON HVPS CAPACITOR BANK IS OUTSIDE SPECIFICATION.), IT COULD NOT BE USED EVEN AFTER RESTARTING. DUE TO THIS, ANOTHER DEVICE WAS USED BUT THE STONE WAS IMPACTED IN THE URETER AND THE APPROACH WAS IMPOSSIBLE, SO THE PROCEDURE WAS WITHDRAWN. 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 20054922 ↗
• MalfunctionMay 22, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE PRESENTED LOW OUTPUT MODE DURING ITS USE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372259 ↗
• MalfunctionDec 14, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SCREEN DISPLAYED ATTACH FOOTSWITCH WHEN THE FOOTSWITCH WAS STEPPED ON. THE PROCEDURE WAS DISCONTINUED AND 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 18326194 ↗
• MalfunctionNov 7, 2023Device Displays Incorrect Message; Output below Specifications; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT, AFTER THE PATIENT HAD BEEN SEDATED FOR A PROCEDURE, THE CONSOLE DISPLAYED A RED SCREEN, INDICATING CASE SAVER MODE. AN ERROR CODE "ALL LASER MALFUNCTION" WAS ALSO DISPLAYED. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. 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 18083440 ↗
• MalfunctionOct 12, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING PREPARATION OF THE CONSOLE FOR A TRANSURETHRAL URETEROLITHOTRIPSY PROCEDURE ERROR CODE 201 (SHUTTER TEST FAILED) DISPLAYED ON THE CONSOLE SCREEN. THE CONSOLE WAS REBOOTED, BUT THE ISSUE PERSISTED. THERE WERE NO PATIENT COMPLICATIONS, BUT THE PROCEDURE WAS CANCELLED/POSTPONED. 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 17919437 ↗
• MalfunctionDec 13, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERROR F205: "NEITHER OPTOCOUPLERS FOR THE SHUTTER SEES LIGHT." DISPLAYED. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. 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 15971828 ↗