Lumenis Pulse 100H (UDI 07290109140520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 07290109140520), received between Jan 9, 2019 and Sep 24, 2026 — classified as 3 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891869 ↗
• MalfunctionAug 18, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306557 ↗
• MalfunctionApr 22, 2026Output below Specifications

  IT WAS REPORTED THAT THE DEVICE HAD A LOW POWER. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957410 ↗
• MalfunctionApr 22, 2026Nonstandard Device; Smoking; Noise, Audible

  IT WAS REPORTED THAT DURING PROCEDURE, A LOUD BANG WAS HEARD, AND A BURNING SMELL WAS NOTICED. THE SYSTEM WAS DOWN. IT WAS INDICATED THAT THE BLAST SHIELD WAS BURNT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956172 ↗
• MalfunctionMar 30, 2026Smoking; Noise, Audible

  IT WAS REPORTED THAT AN ABNORMAL NOISE AND A BURNING SMELL WERE NOTICED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716393 ↗
• MalfunctionMar 25, 2026Output below Specifications

  IT WAS REPORTED THAT THE OPTIC WAS FOUND BLOWN RESULTING IN LOW POWER OUTPUT. THE CONSOLE IS NOT USED TO TREAT PATIENTS BUT IS USED FOR TEST ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689561 ↗
• MalfunctionMar 17, 2026Output below Specifications

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, IT WAS NOTICED BY THE PHYSICIAN THAT THE CONSOLE HAD LACK OF POWER. ALSO, THE DEBRIS SHIELD WAS CHANGED TWICE IN 10 DAYS. NO FURTHER INFORMATION ABOUT THE PATIENT AND PROCEDURE OUTCOME ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618247 ↗
• MalfunctionMar 9, 2026Output below Specifications

  IT WAS REPORTED THAT DURING PREPARATION, THE DEVICE SHOWED LOW POWER WHILE LASING, ALTHOUGH NO ERROR APPEARED ON THE SCREEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552622 ↗
• MalfunctionFeb 17, 2026Unexpected Shutdown

  IT WAS REPORTED THAT DURING PREPARATION FOR A RETROGRADE INTRARENAL SURGERY (RIRS), THE DEVICE TURNS ON MOMENTARILY, THEN SHUTS ITSELF OFF. 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 24369177 ↗
• MalfunctionFeb 16, 2026Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAD LOW POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24354992 ↗
• MalfunctionJan 7, 2026Nonstandard Device; Output below Specifications; Power Problem

  IT WAS REPORTED THAT THIS DEVICE IS GETTING LOW POWER AND BURNED BLAST SHIELD. THERE WERE NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993093 ↗
• MalfunctionJan 5, 2026Smoking

  IT WAS REPORTED THAT DURING PROCEDURE, A BURNT SMELL WAS NOTICED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969076 ↗
• MalfunctionJan 5, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT PRIOR TO THE RETROGRADE INTRARENAL URETEROSCOPY SURGERY (RIRS) PROCEDURE, THE CONSOLE DISPLAYED ERROR CODE 405 - FOOTSWITCH #1 SHORTED. THE CASE WAS POSTPONED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959490 ↗
• MalfunctionDec 8, 2025Output below Specifications; Noise, Audible; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT THE CONSOLE HAD A NOISE AND LOW POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743784 ↗
• MalfunctionDec 2, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT THERE WAS A DEBRIS SHIELD PROBLEM. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE CONSOLE WAS INSPECTED AND WAS A LOW POWER OUTPUT IN FOURTH CAVITY, THEREFORE, THE BRICK ASSEMBLY WAS REPLACED. THE CONSOLE WAS ALIGNED AND WORKED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694934 ↗
• MalfunctionNov 18, 2025Smoking; Smoking

  IT WAS REPORTED THAT THE CONSOLE WAS HAVING BURN SMELL DURING USE. THERE WAS NO PROCEDURE AND PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580477 ↗
• MalfunctionNov 13, 2025Smoking; Smoking

  IT WAS REPORTED THAT A BURNING SMELL WAS NOTICED COMING FROM THE CONSOLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550694 ↗
• MalfunctionOct 29, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE POWER OF THIS DEVICE WAS LOWER THAN USUAL WHEN SHOOTING. THERE WERE NO REPORT OF PATIENT OR PROCEDURE INVOLVED. 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 23420575 ↗
• MalfunctionOct 16, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT, DURING PREPARATION OF THE PROCEDURE, WHEN ATTACHING THE FIBER TO THE CONSOLE, THE CONSOLE SHUT DOWN WITHOUT AN ERROR CODE. ALSO, WHEN THE FIBER WAS ALREADY ATTACHED, THE CONSOLE ALSO SHUT DOWN. THE PROCEDURE WAS CANCELLED DUE TO THE ISSUE. THE PATIENT WAS ALREADY UNDER SEDATION AND THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316966 ↗
• MalfunctionSep 29, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT AN UNUSUAL NOISE WAS HEARD COMING FROM THE LASER MACHINE. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER UNKNOWN ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23176024 ↗
• MalfunctionSep 23, 2025Smoking; Smoking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE BANGED AND THERE WAS SMOKE NOTICED. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23124764 ↗
• MalfunctionAug 20, 2025Melted; Melted

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER CAUGHT ON FIRE. THERE WAS NO FURTHER INFORMATION REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND PROCEDURE OUTCOME, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856233 ↗
• MalfunctionAug 11, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE DEVICE PROMPTED AN ERROR CODE 501 (NO POWER TO HVPS.) THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779497 ↗
• MalfunctionAug 7, 2025Defective Device; Output below Specifications; Defective Device; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAD LOW POWER. THERE WAS NO ERROR CODE DISPLAYED ON THE SCREEN, NO RED SCREEN AND NO CASE SAVER MODE ACTIVATED; THE USER HAD SIMPLY NOTICED LOWER PERFORMANCE. IT WAS NOTED THAT THE LOW POWER WAS DUE TO A DAMAGED ENERGY SENSOR BOARD, WHICH WAS REPLACED DURING THE REPAIR PROCESS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740248 ↗
• MalfunctionJul 28, 2025Smoking; Noise, Audible; Smoking; Noise, Audible

  IT WAS REPORTED THAT DURING FIRING, THE DEVICE HAD A LOUD POPPING SOUND AND BURNING SMELL. THERE WAS NO REPORT OF PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636761 ↗