Vectus 105-3500-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841494100124), received between Jul 13, 2020 and Nov 14, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unexpected/Unintended Radiation Output” (5 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 18, 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.

• InjuryNov 14, 2025Use of Device Problem; Use of Device Problem

  SITE REPORTED PROVIDER ACCIDENTALLY LASERED PATIENT'S TATTOO ON THE LEG DURING A LASER HAIR REMOVAL TREATMENT USING VECTUS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23555064 ↗
• MalfunctionJan 28, 2022Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT THE VECTUS WAS FIRING EVEN WHEN THE FOOT PEDAL AND TRIGGER WAS NOT IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384512 ↗
• InjuryOct 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EXPERIENCED A BURN THAT RESULTED IN HYPOPIGMENTATION FROM A TREATMENT USING VECTUS ON (B)(6) 2020. CYNOSURE WAS NOTIFIED ON 9/9/2021.

  Patient problems: Skin Discoloration

  MAUDE report 12602222 ↗
• MalfunctionJul 21, 2021Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT A DEVICE MALFUNCTION CAUSED THE FINGER SWITCH ON THE HANDPIECE TO JAM AND EVENTUALLY FIRE, RESULTING IN DAMAGE TO THE PATIENT'S BED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204832 ↗
• MalfunctionOct 16, 2020Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  CUSTOMER REPORTED THAT THE DEVICE'S HANDPIECE FIRED ON ITS OWN. NO FOOT PEDAL WAS PLUGGED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10690818 ↗
• MalfunctionAug 19, 2020Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  CUSTOMER REPORTED THAT THE DEVICE DOUBLE FIRES WHEN THE HANDPIECE IS TRIGGERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10428442 ↗
• MalfunctionJul 13, 2020Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT THE VECTUS RELEASED AN UNINTENDED RADIATION OCCURRENCE AND BURNED A SITE STAFF MEMBER'S UPPER LIP.

  Patient problems: Burn(s)

  MAUDE report 10263239 ↗