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POLLOGEN LEGEND POLLOGEN LEGEND+Recalls & reported problems

Pollogen Ltd · The Pollogen Legend+ system is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3). Pollogen Legend+ system is composed of a console, VO hand held applicator and disposable tips, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins. It is also composed of 3 treatment applicators, foot switch and patient-controlled manual switch. User interface allows the selection of treatment parameters: applicator, power and time and displays the current settings. The RF module provides RF energy to applicators at 1 MHz frequency. The treatment applicators transmit Bi-Polar RF energy through multiple electrode configuration which produces homogenous heating of the treatment area. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290016586008), received between Feb 28, 2017 and Feb 28, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

Device problems

  • Insufficient Device Problem Information1
  • Unexpected Therapeutic Results1

Patient problems

  • Burn(s)1
  • Therapeutic Effects, Unexpected1

Recent adverse event reports

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

  • InjuryFeb 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED BURNS AND BLISTERS TO THE LEG FOLLOWING TREATMENT WITH A POLLOGEN LEGEND + RF DEVICE. NO REPORT OF MEDICAL INTERVENTION WAS RECEIVED FROM THE USER FACILITY OTHER THAN THE INITIAL REPORT. ADDITIONALLY, THE USER FACILITY SUGGESTED THE USE OF BACITRACIN, AN OVER THE COUNTER ANTIBIOTIC OINTMENT TO THE PATIENT.

    Patient problems: Burn(s)

    MAUDE report 6365806 ↗
  • InjuryFeb 28, 2017Unexpected Therapeutic Results; Unexpected Therapeutic Results

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED AN UNTYPICAL REACTION OF UNKNOWN SEVERITY FOLLOWING TREATMENT WITH A POLLOGEN LEGEND+ RF DEVICE. NO REPORT OF MEDICAL INTERVENTION WAS RECEIVED FROM THE USER FACILITY OTHER THAN THE INITIAL REPORT.

    Patient problems: Therapeutic Effects, Unexpected

    MAUDE report 6365713 ↗

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Sources and updates

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