VASER 110-0036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850608002520), received between May 29, 2025 and May 29, 2025 — 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.

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 29, 2025Suction Problem; Noise, Audible; Key or Button Unresponsive/not Working; Suction Problem; Noise, Audible; Key or Button Unresponsive/not Working

  A USER FACILITY REPORTED TO THE DISTRIBUTER THAT THE BUTTON TO SELECT THE SUCTION MODE (S) DID NOT START AFTER PRESSING IT. IT ONLY STARTED AFTER ABOUT 15 MINUTES AND WAS MAKING AN UNUSUAL NOISE. THE SUCTION WAS DISCONNECTED AND THE MOMENT IT WAS TURNED BACK ON, TIME WAS LOST AGAIN FOR IT TO START. THE TREATMENT WAS ABLE TO BE COMPLETED USING ANOTHER DEVICE. THIS CAUSED A DELAY OF 60 MINUTES OR GREATER FOR THE LENGTH OF TIME THE PATIENT WAS UNDER GENERAL ANESTHESIA. IN ACCORDANCE WITH INTERNAL GUIDELINES, THE EVENT WAS ASSESSED AS A SERIOUS INCIDENT AND DEEMED REPORTABLE DUE TO THE SIGNIFICANT PROLONGATION OF THE PROCEDURE (GREATER THAN 60 MINUTES), WHICH MAY INCREASE RISK TO THE PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109754 ↗