VASER 110-0021Recalls & reported problems
Solta Medical · VASER 2.2 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850608002483), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (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.
Reports received per month
Most reported problems
Device problems
- Key or Button Unresponsive/not Working1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM WAS TESTED PRIOR TO USE. THE MACHINE WAS SWITCHED ON AND ALL SWITCHES/BUTTONS WERE CHECKED AND WORKED. HOWEVER, DURING THE PROCEDURE, THE BUTTON'S CHANGE MODE DID NOT FUNCTION. THE TOTAL TIME OF THE VASER DELIVERY WAS ABOUT 8 MINUTES. THE PROCEDURE WAS COMPLETED USING SUCTION FROM AN ANESTHETIC MACHINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19628681 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.