VIVACE Electrosurgical SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08800017100326), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 13, 2020Terminated

   A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

   Z-0444-2021 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT RECEIVED FACIAL TREATMENTS OF FILLER AND NEUROMODULATORS 4 WEEKS PRIOR TO THE VIVACE TREATMENT. THE TREATMENT RESULTED IN THE FILLER AND NEUROMODULATORS MELTING AWAY, LEAVING THE PATIENT'S FACE SAGGING. THE PROVIDER HAD PLANNED A SERIES OF TREATMENTS WITH THE VIVACE DEVICE AND INCLUDED A TREATMENT FOR INJECTIONS BETWEEN THE FIRST AND SECOND VIVACE TREATMENTS. VIVACE TREATMENT ONE WAS PERFORMED ON (B)(6) 2020. THE FILLER INJECTIONS WERE PERFORMED (B)(6) 2020. THE SECOND VIVACE TREATMENT WAS THE SUBJECT OF THIS REPORT, PERFORMED ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10857615 ↗