DermaVRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08800291820200), received between Jun 9, 2026 and Jun 11, 2026 — classified as 2 malfunctions.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 6, 2026Open, Classified

   Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

   Z-3110-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RED FLASH AND LOUD NOISE OCCURRED DURING 1064NM VASCULAR TREATMENT USING DERMAV. SPARK AND SOOT WERE NOTED.

  Patient problems: Burn(s)

  MAUDE report 25472998 ↗
• MalfunctionJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RED FLASH AND LOUD NOISE OCCURRED DURING 1064NM VASCULAR TREATMENT USING DERMAV. SPARK AND SOOT WERE NOTED. CYNOSURE LUTRONIC TECHNOLOGY (CLT) CLINICAL TEAM CONTACTED THE SITE TO INVESTIGATE THE EVENT. SITE INFORMED CLT CLINICAL THAT THE PATIENT EXPERIENCED A BURN. ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THERE WAS NO ADDITIONAL INFORMATION MADE AVAILABLE FROM THE CUSTOMER SITE DESPITE MULTIPLE REQUESTS FROM CLINICAL. BURNS ARE AN EXPECTED SIDE EFFECT FROM SUCH TREATMENT. A TRAINED CYNOSURE FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO PERFORM A DEVICE EVALUATION. FSE CHECKED THE ENERGY OUTPUT ON BOTH 1064 AND 532 WAVELENGTHS, CONFIRMING THEY WERE WITHIN SPECIFICATIONS AND IN NORMAL RANGE. BURN SHOTS ALSO APPEARED NORMAL. FSE THEN VERIFIED ALL SETTINGS AND TESTED THE UNIT THOROUGHLY WITH NO ISSUES FOUND. THIS EVENT IS REPORTABLE UNDER FDA MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR PART 803), AS IT INVOLVES AN OBSERVED DEVICE MALFUNCTION THAT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

  Patient problems: Burn(s)

  MAUDE report 25446585 ↗