Venus Vila GLB system VI102402GLBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290016541052), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INVESTIGATION ANALYSIS: VENUS CONCEPT WAS NOTIFIED ON 11/28/2025 OF MEDICAL DEVICE REPORT (MDR) - MW5178619 DATE OF THIS REPORT: 03-NOV-2025 MDR WAS SUBMITTED TO THE FDA. EVENT DESCRIPTION: ON 31-OCT-2025 - "I WAS SUBMITTED TO TREATMENT USING VENUS VIVA RF EQUIPMENT. THE NEXT DAY, I WOKE UP WITH MODERATE FACIAL SWELLING, ESPECIALLY IN THE CHEEK AREA. ON THE SECOND DAY, MY EYES AND THE AREA AROUND MY MOUTH BECAME SWOLLEN. I HAD TO SEEK MEDICAL ATTENTION BECAUSE I WAS AFRAID IT MIGHT AFFECT MY BREATHING. THIS WAS MY FIRST SESSION." LABELING: PER VENUS VIVA USER MANUAL, UMVIGLB REV L A.6.3. EXPECTED CLINICAL EFFECTS AND POSSIBLE SIDE EFFECTS DURING OR IMMEDIATELY AFTER THE TREATMENT, CERTAIN EFFECTS AND RESPONSES MAY OCCUR. ALTHOUGH THESE EFFECTS ARE EXPECTED AND TRANSIENT, ANY ADVERSE REACTION SHOULD BE IMMEDIATELY REPORTED TO THE PHYSICIAN. SIDE EFFECTS MAY APPEAR EITHER AT THE TIME OF THE TREATMENT OR AFTER IT. EXPECTED CLINICAL EFFECTS AND POSSIBLE SIDE EFFECTS MAY INCLUDE: TRANSIENT EXCESSIVE SKIN REDNESS (ERYTHEMA) AND/OR SWELLING (EDEMA) MAY OCCUR. B.8. TEST TREATMENT CAUTION: IN ORDER TO PREVENT ADVERSE EFFECTS, TEST SPOTS SHOULD BE PERFORMED BEFORE EACH TREATMENT AND UPON CHA

  Patient problems: Swelling/ Edema

  MAUDE report 23849037 ↗