VIVACE ULTRA VERSION 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI G055ABMVIVS020), received between May 4, 2026 and May 4, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 2026.

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.

• InjuryMay 4, 2026Use of Device Problem

  A PRACTICE CONTACTED AESTHETICS BIOMEDICAL (ABM) WITH AN IMAGE OF A PATIENT WITH HYPERTROPHIC SCARRING AND HEALING LESIONS ON THEIR ABDOMEN AFTER A RECENT ULTRAVISION TREATMENT. ABM'S CHIEF MEDICAL OFFICER (CMO) IMMEDIATELY INITIATED CONTACT WITH THE PRACTICE TO SPEAK WITH THE PRACTITIONER TO GAIN MORE KNOWLEDGE AND UNDERSTANDING ABOUT THE TREATMENT. THE CMO SPOKE WITH THE PRACTICE OWNER WHO PROVIDED INFORMATION THAT WAS CONTAINED IN THE PATIENT CHART. THE SETTINGS THAT WERE PROVIDED TO THE CMO INCLUDED POWER LEVCEL 8 (40 WATTS), 700 MS, 1 MHZ, 2 PASSES AT A DEPTH OF 3.9 MM WITH A 60-ARRAY INSULATED NEEDLE SET. THE TREATMENT PARAMETERS WERE NOT WITHIN ABM'S SUGGESTED TREATMENT GUIDELINES FOR THE TARGET TISSUE. THE CMO ATTEMPTED TO OBTAIN MORE INFORMATION, REQUESTING THAT SHE BE ABLE TO SPEAK WITH THE AESTHETICIAN WHO PERFORMED THE TREATMENT BUT WAS NOT GIVEN THE OPPORTUNITY.

  Patient problems: Scar Tissue

  MAUDE report 25073326 ↗