AcuPulse™ DUORecalls & reported problems
Lumenis Ltd. · Class 2
Quick summary
This Lumenis AcuPulse DUO is a powered laser surgical instrument. Its 79 reports, with no deaths and 4 injuries, mostly describe malfunctions (75 reports): the aiming beam not lining up with the treatment laser, a misaligned articulated arm, and console error messages that force procedures to be cancelled. A few reports mention burns. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 76
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 07290109140292), received between Oct 12, 2022 and Sep 21, 2026 — classified as 4 injuries, 72 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (25 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.
Reports received per month
Most reported problems
Device problems
- Failure to Align25
- Appropriate Device Problem Term/Code Not Available22
- Defective Device12
- Adverse Event Without Identified Device or Use Problem10
- Output below Specifications7
- Device Displays Incorrect Message6
- Nonstandard Device4
- Failure to Power Up3
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Burn(s)2
- Inflammation1
- Insufficient Information1
- Partial thickness (Second Degree) Burn1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Nonstandard Device; Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847386 ↗MalfunctionSep 18, 2026Failure to Align
It was reported that the micromanipulator was not properly aligned when used with the laser. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828043 ↗MalfunctionSep 14, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765330 ↗MalfunctionAug 21, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50378994 ↗MalfunctionJul 6, 2026Failure to Fire; Material Integrity Problem
IT WAS REPORTED THAT DURING PREPARATION, THE MICROMANIPULATORS LENS HAD A BLACK SPOT, AND THE AIMING BEAM WAS NOT VISIBLE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER UNKNOWN SEDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25728388 ↗MalfunctionJun 10, 2026Fire
It was reported that the fiber went into flames for a second. The case had to be cancelled.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464006 ↗MalfunctionMay 8, 2026Nonstandard Device
IT WAS REPORTED THAT THE EMERGENCY STOP BUTTON WAS DAMAGED, AND THE PREVENTIVE MAINTENANCE COULD NOT BE COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25127773 ↗MalfunctionMay 7, 2026Failure to Align
IT WAS REPORTED THAT THE MICROMANIPULATOR HAD ALIGNMENT ISSUE. NO INFORMATION REGARDING PATIENT AND PROCEDURE WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25119673 ↗MalfunctionApr 30, 2026Failure to Align
IT WAS REPORTED THAT DURING A PROCEDURE THE AIMING AND THE IRRADIATION POSITION WERE MISALIGNED. 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 25045407 ↗MalfunctionApr 27, 2026Failure to Align
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE AIMING BEAM WAS MISALIGNED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25000185 ↗MalfunctionApr 7, 2026Failure to Align
IT WAS REPORTED THAT PRIOR THE PROCEDURE, THE ARM PRESENTED ALIGNMENT PROBLEMS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811716 ↗MalfunctionApr 7, 2026Failure to Align
IT WAS REPORTED THAT THE MICROMANIPULATOR REQUIRES ALIGNMENT WITH THE LASER DUE TO OBSERVED BEAM IRREGULARITIES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810872 ↗MalfunctionMar 6, 2026Failure to Align
IT WAS REPORTED THAT DURING PREPARATION, ANOMALIES WERE OBSERVED BETWEEN THE LASER DOT AND THE ADJUSTMENT LEVER, AS THEY WERE NOT IN THE CORRECT POSITIONS. THESE OBSERVATIONS WERE SPECIFICALLY ASSOCIATED WITH THE MICROMANIPULATOR, AS THE JOYSTICK DID NOT FUNCTION AS EXPECTED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE; HOWEVER, NO DETAILS REGARDING THE PATIENT OUTCOME WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24534543 ↗MalfunctionMar 2, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT THE FOOT PEDAL KEEPS GETTING STUCK. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24491798 ↗MalfunctionFeb 24, 2026Failure to Align; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING PREPARATION, THE MICROMANIPULATOR EXPERIENCED A FOCUS AND ALIGNMENT ANOMALY. NO PROCEDURE NOR PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434632 ↗MalfunctionJan 5, 2026Failure to Align
IT WAS REPORTED THAT THE DEVICE'S BEAM IS OFF ALIGNMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956205 ↗MalfunctionDec 9, 2025Nonstandard Device; Failure to Align; Nonstandard Device; Failure to Align
IT WAS REPORTED THAT THE HANDPIECE SCANNER WAS UNABLE TO COMPLETE A FULL CIRCLE DURING IMAGING. THERE WAS NO PROCEDURE AND PATIENT OUTCOME REPORTED. THE CONSOLE WAS INSPECTED AND WAS FOUND THAT THE ARM WAS OUT OF ALIGNMENT, THEREFORE, REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23761841 ↗MalfunctionDec 8, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT DURING INSTALLATION OF CONSOLE, IT WAS NOTED THAT THE ARM ALIGNMENT WAS LOST. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744852 ↗MalfunctionDec 8, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT THE MICROMANIPULATOR IS NOT FOCUSING. 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 23744052 ↗MalfunctionDec 4, 2025Failure to Align; Failure to Align
IT WAS REPORTED BY THE CUSTOMER THAT DURING PREPARATION OF CO2 CONSOLE FOR A PROCEDURE, IT WAS OBSERVED THAT IT WAS FIRING AT THREE DIFFERENT POINTS. THERE WAS NO PATIENT INVOLVED AT THE TIME OF THE OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23722450 ↗MalfunctionNov 4, 2025Nonstandard Device; Appropriate Device Problem Term/Code Not Available; Nonstandard Device; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CONSOLE AIMING BEAM WAS OFF. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465370 ↗MalfunctionOct 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE AIMING BEAM IS OUT OF ALIGNMENT. 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 23312725 ↗MalfunctionSep 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THERE WAS AN ALIGNMENT ISSUE WITH THE CONSOLE, AS WHEN USE IT, IT FIRED OFF TARGET. THE CASE WAS CANCELLED AND THERE WAS NO PATIENT INVOLVED AT THE MOMENT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23133777 ↗MalfunctionSep 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT BEFORE THE PROCEDURE, IT WAS FOUND OUT THAT THE AIMING BEAM WAS MISALIGNED BY MINUS 1 MM TO MINUS 1.5 MM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073039 ↗MalfunctionSep 12, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT THE MICROMANIPULATOR IS MISALIGNED. 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 23041770 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.