Lumenis Pulse 30H (REF GA-2006098)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07290109145990), received between Sep 24, 2022 and Jul 30, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50093910 ↗
• MalfunctionJan 28, 2026Smoking; Noise, Audible

  IT WAS REPORTED THAT DURING PREPARATION, THE DEVICE HAD A LOUD BANG AND A BURNING SMELL. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202421 ↗
• MalfunctionDec 29, 2025Failure to Fire; Noise, Audible; Failure to Fire; Noise, Audible

  IT WAS REPORTED THAT DURING A LASER LITHOTRIPSY PROCEDURE TO CRUSH KIDNEY STONES, THE CONSOLE MADE AN UNUSUAL NOISE, AND THERE WERE NO MORE LASER SHOTS BEING FIRED. THE PHYSICIAN WAS UNABLE TO COMPLETE THE LITHOTRIPSY AND DECIDED TO PLACE A URETERAL STENT AND THE PROCEDURE WILL BE COMPLETED ANOTHER TIME. 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 23908591 ↗
• MalfunctionSep 26, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT THE ENERGY OUTPUT OF THIS DEVICE WAS TOO LOW. THERE WERE NO REPORT OF PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23159478 ↗
• MalfunctionSep 24, 2025Smoking; Output below Specifications; Noise, Audible; Smoking; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT THERE WAS SMELL AND VIBRATIONS FROM CONSOLE. ALSO, THERE WAS A STRANGE NOISE AND LOW POWER WITHIN THE CONSOLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23133499 ↗
• MalfunctionSep 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PROCEDURE, THE FOOT PEDAL OF THIS DEVICE WAS STUCKED AND PROMPTED AN ERROR CODE 7 (FOOTSWITCH PRESSED (DURING SELF-TEST & ENTER READY) - RELEASE THE FOOTSWITCH). THERE WERE NO REPORTS OF PATIENT OR PROCEDURE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100061 ↗
• MalfunctionAug 25, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING PROCEDURE, THE CONSOLE WAS NOT GETTING ENOUGH POWER AND THERE IS AN AIMING BEAM ISSUE RELATED TO ITS LIGHT BRIGHTNESS. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884544 ↗
• MalfunctionApr 7, 2025Smoking; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Smoking; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE INSTALLATION OF THIS SYSTEM, THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE DEVICE EXPLODED AND STARTED TO SMOKE FROM THE CHARGER LOCATION. ERROR 25 (CHARGER FAULT) WAS ALSO DISPLAYED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21793460 ↗
• MalfunctionMar 26, 2025Use of Device Problem; Defective Device; Material Integrity Problem; Use of Device Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT, THE EMERGENCY STOP ASSEMBLY IS BROKEN/DAMAGED. 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 21700668 ↗
• MalfunctionJan 20, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE IS NOT ABLE TO GO HIGHER THAN 5 WATTS OR RATE OVER 25 HZ. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194180 ↗
• MalfunctionDec 19, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE FIBER WAS OR RECOGNIZED BY THE SYSTEM, "FIBER CANNOT BE CONNECTED" MESSAGE WAS PROMPTED BY THE SYSTEM. THE PROCEDURE COULD NOT BE COMPLETED, THE PHYSICIAN PLACED A BALLOON DEVICE TO PLACE A STENT INSTEAD. 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 20976722 ↗
• MalfunctionNov 22, 2024Smoking; Noise, Audible; Unexpected Shutdown; Smoking; Noise, Audible; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE WAS LASERING FOR ABOUT 15 MINUTES ON A LIGHT DUSTING SETTING. THEN, A LOUD POP/EXPLOSION WAS HEARD, THE SCREEN WENT BLACK, THE CONSOLE RESTARTED BY ITSELF AND SUDDENLY SMOKE CAME OUT FROM THE BACK OF THE DEVICE. THE CONSOLE WAS SHUT IT DOWN AND UNPLUGGED IT IMMEDIATELY. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757384 ↗
• MalfunctionMay 22, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT THE LASER IS NOT FIRING. THE LASER WAS RESTARTED 3 TIMES, THE FIBER WAS REPLACED, THE FOOTSWITCH WAS UNPLUGGED AND REPLUGGED, BUT THE ISSUE PERSISTED. 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 19372775 ↗
• MalfunctionApr 19, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT PRIOR TO A FLEXIBLE LITHOTRIPSY PROCEDURE, WHEN THE SYSTEM WAS TURNED ON, THE DISPLAY APPEARS REDDISH. THE CONNECTORS ON THE DISPLAY AND CPU CONTROLLER WERE RECONNECTED, BUT THE ISSUE PERSISTED, AND THE CUSTOMER REQUESTED A DISPLAY REPLACEMENT. THE PATIENT WAS UNDER GENERAL ANESTHESIA, BUT THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS RESCHEDULED DUE TO THE EVENT. 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 19144792 ↗
• MalfunctionMar 14, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED BY THE DISTRIBUTOR THAT, DURING THE PROCEDURE TO TREAT STONES, WHEN THE CONSOLE IS STARTED IT TURNS OFF DURING AUTO-TEST AND THEN STARTS AGAIN. THIS HAPPENS EVERY TIME. THE LVPS AND THE CHARGER WERE CHANGED, BUT THE ISSUE HAS NOT RESOLVED. THE VOLTAGE OUTPUT OF THE LVPS IS CORRECT AT 380 VOLTS. THE DISTRIBUTOR IS REQUESTING ADVICE ON WHAT TO CHANGE OR CHECK ON THE CONSOLE TO RESOLVE THE ISSUE. THE PATIENT HAD BEEN SEDATED WITH GENERAL ANESTHESIA PRIOR TO THE PROCEDURE. THE PROCEDURE WAS THEN CANCELLED. 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 18905474 ↗
• MalfunctionAug 31, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THAT DURING INTRODUCTION, THE SELF TEST UNIT FAILED. 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 WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664785 ↗
• MalfunctionAug 29, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE RING AROUND THE FIBER PORT WAS MISSING, AND THE FIBERS ARE NOT CONNECTING. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. 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 17643110 ↗
• MalfunctionAug 15, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE NEEDS A REPLACEMENT OF THE KEY SWITCH. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. 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 17548458 ↗
• MalfunctionAug 2, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CUSTOMER IS GETTING FOOT PEDAL ERRORS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444227 ↗
• MalfunctionJul 17, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT URETER STONES, ERROR 35 WAS RECEIVED. AFTER A WHILE, THEY COULD NOT USE THE EQUIPMENT ANYMORE. THE PROCEDURE WAS THEN CANCELLED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337828 ↗
• MalfunctionJan 13, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TURNING ON THE UNIT AND ATTEMPTING TO FIRE THE LASER, AN ERROR MESSAGE STATING TO RESTART THE SYSTEM WAS DISPLAYED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH PATIENT WITH OR UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164798 ↗
• MalfunctionSep 24, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, ERROR 66 (USE AUTHORIZED FIBER) DISPLAYED ON THE CONSOLE SCREEN, AND THE SYSTEM WAS NOT RECOGNIZING THE FIBERS. THE CUSTOMER ONLY HAD 2 FIBERS FROM THE SAME LOT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS ALREADY SEDATED WHEN THE EVENT OCCURRED. THERE WAS NO REPORTED PERMANENT IMPAIRMENT OR INJURY TO THE PATIENT. 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 15477585 ↗