Lumenis Pulse, Moses 2.0 (INT)Recalls & reported problems
Lumenis Ltd. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290109147208), received between Jul 9, 2025 and Apr 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Noise, Audible” (2 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.
Reports received per month
Most reported problems
Device problems
- Noise, Audible2
- Nonstandard Device2
- Smoking2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Nonstandard Device; Noise, Audible
IT WAS REPORTED THAT A CRACKING SOUND WAS NOTICED DURING THE PROCEDURE, AND THE DEBRIS SHIELD BURNED. 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 WHOSE SEDATION STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825152 ↗MalfunctionDec 9, 2025Smoking; Noise, Audible; Smoking; Noise, Audible
IT WAS REPORTED THAT THE SYSTEM WAS NOISY AND WHITE SMOKE CAME OUT FROM THE LEFT OF THE FRONT OF 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 23753553 ↗MalfunctionJul 9, 2025Nonstandard Device; Smoking; Nonstandard Device; Smoking
IT WAS REPORTED THAT LASER SMELLS HOT AND THERE WAS SMOKE. 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 22457701 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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