DermaV COMPL_BODY_ICD_SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08809447655277), received between Aug 29, 2025 and May 8, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Unexpected/Unintended Radiation Output” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A VASCULAR TREATMENT ON THE LEG A BRIGHT PULSE WAS OBSERVED WITH A DERMAV LASER DEVICE. SOOT WAS NOTED ON THE PATIENT'S SKIN IMMEDIATELY FOLLOWING THE PULSE, HOWEVER, THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122843 ↗
• MalfunctionFeb 27, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A DERMAV DEVICE SPARKED, MADE A LOUD POPPING SOUND AND LEFT A BLACK SOOT MARK ON THE PATIENT. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE FOR DEVICE EVALUATION. WHILE ON SITE, THE SYSTEM WAS IN USE DURING A TREATMENT SESSION BY THE PROVIDER. THE FSE WAS PRESENT WHILE THE TREATMENT WAS BEING PERFORMED. DURING THE TREATMENT THE FSE OBSERVED THE DEVICE MAKE A LOUD POP, SPARK AND LEAVE A BLACK SOOT MARK ON THE PATIENT. THE BLACK SOOT WAS WIPED AWAY AND THERE WAS NO VISIBLE BURN OR INJURY PRESENT. FOLLOWING THIS OBSERVATION, THE DEVICE WAS SUBJECTED TO MULTIPLE TESTS BY THE FSE INCLUDING: FULL FUNCTIONALITY CHECK, ENERGY TESTING, AND CRYOGEN TESTING ALL WITH PASSING RESULTS. THE DISTANCE GAUGE AND INTELLITRAK WERE VISUALLY INSPECTED FOR ANY EVIDENCE OF BURN MARKS OR OTHER DAMAGE WITH NO DISCREPANCIES OBSERVED. THE DEVICE WAS FOUND TO BE OPERATING WITHIN PUBLISHED SPECIFICATIONS. IT IS UNKNOWN WHAT CAUSED THE REPORTED ISSUE. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER AND DETERMINED THAT THE TREATMENT PARAMETERS USED WERE 10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472117 ↗
• MalfunctionFeb 27, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A DERMAV DEVICE SPARKED, MADE A LOUD POPPING SOUND AND LEFT A BLACK SOOT MARK ON THE PATIENT. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471459 ↗
• MalfunctionSep 3, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT WHILE PROVIDER WAS USING THE INTELLITRAK, THE HANDPIECE WAS LIFTED OFF THE TISSUE AND WENT TO THE NEXT ROW. IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR PROVIDER INJURY. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE FOR DEVICE EVALUATION. DURING THIS TIME, THE REPORTED ISSUE OF INTERMITTENT MISFIRING WAS VERIFIED. THE INTILLITRAK TIP WAS FOUND TO BE DEFECTIVE AND TO CORRECT THE ISSUE A NEW TIP WAS ORDERED FOR THE CUSTOMER. THIS EVENT IS A REPORTABLE EVENT SINCE THIS IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) DUE TO DEVICE FIRING UNINTENTIONALLY ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954452 ↗
• MalfunctionSep 3, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT WHILE PROVIDER WAS USING THE INTELLITRAK, THE HANDPIECE WAS LIFTED OFF THE TISSUE AND WENT TO THE NEXT ROW. IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR PROVIDER INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953538 ↗
• MalfunctionAug 29, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT THE DERMAV WOULD CONTINUE TO FIRE AFTER PROVIDER LIFTED HANDPIECE OFF THE PATIENT. SITE TRIED TO CHANGE THE TIPS, BUT STILL EXPERIENCING THE SAME ISSUE. NO INJURIES WERE REPORTED. CYNOSURE FIELD SITE ENGINEER (FSE) ARRIVED ON SITE AND EVALUATED THE DEVICE. FSE WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. FSE ALSO TRIED TO USE DIFFERENT INTELLITRAK TIPS WITH THE LASER, BUT SPOT SIZES COULDN'T BE RECOGNIZED, AND TIPS CANNOT BE USED. FSE RELAYED TO CYNOSURE TECH SUPPORT THAT THE HANDPIECE NEED TO BE REPLACED. DUE TO THE SITE REPORTING AN UNINTENDED DISCHARGE OF LASER ENERGY, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922531 ↗
• MalfunctionAug 29, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT THE DERMAV WOULD CONTINUE TO FIRE AFTER PROVIDER LIFTED HANDPIECE OFF THE PATIENT. SITE TRIED TO CHANGE THE TIPS, BUT STILL EXPERIENCING THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922424 ↗