VASER 110-0022Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850608002490), received between Apr 17, 2024 and May 14, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Suction Failure” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Suction Problem; Suction Problem

  A USER FACILITY REPORTED THAT THEIR VENTX DID NOT HAVE SUCTION DURING A PROCEDURE WHILE THE PATIENT WAS GENERAL ANESTHESIA. AS A RESULT, THE SURGERY WAS CANCELLED, AND THE PATIENT WAS AWAKENED AFTER 5 MINUTES OF TROUBLESHOOTING. THIS EVENT WAS ASSESSED AS SERIOUS DUE TO THE ABORTED PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022720 ↗
• InjuryJan 21, 2025Suction Failure; Suction Failure

  A USER FACILITY REPORTED A CLICKING SOUND WHEN ACTIVATING THE SUCTION ON THE VASERLIPO SYSTEM, BUT THE PUMP WOULD NOT RUN. THIS RESULTED IN A DELAY OF MORE THAN SIXTY MINUTES WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS ULTIMATELY ABORTED. BOTH THE DELAY OF OVER SIXTY MINUTES WHILE THE PATIENT IS UNDER GENERAL ANESTHESIA AND THE PROCEDURE BEING ABORTED ARE CONSIDERED SERIOUS INCIDENTS PER SOLTA PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200945 ↗
• InjuryJul 10, 2024Decrease in Suction; Battery Problem; Communication or Transmission Problem; Noise, Audible; Decrease in Suction; Battery Problem; Communication or Transmission Problem; Noise, Audible

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENTS THAT OCCURRED DURING THE VASERLIPO SURGERY. THE USER FACILITY ALSO REPORTED ZERO SUCTION WITH THE VACUUM PUMP. PRIOR TO TREATMENT, AN OFF-GRINDING AND CLICKING NOISE WAS COMING FROM BOTTOM OF THE VENTX CONSOLE. NO PAL (POWER ASSISTED LIPO) DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713554 ↗
• InjuryApr 17, 2024Pumping Stopped; Suction Failure; Pumping Stopped; Suction Failure

  A USER FACILITY REPORTED THAT THE DURING A VASERLIPO PROCEDURE, THE PUMP WOULD NOT TURN ON IN THE MIDDLE OF THE PROCEDURE, AND THUS THERE WAS NO SUCTION. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE SURGEON HAD TO ABORT THE PROCEDURE SINCE THE PUMP STOPPED WORKING. NO OTHER EQUIPMENT WAS USED. THE CUSTOMER HAD BEEN USING THE VENTX THROUGHOUT THE PROCEDURE. THEY STOPPED USING THE VENTX FOR A WHILE AND WHEN THEY ATTEMPTED TO USE IT AGAIN THE PUMP WAS NOT TURNING ON. THEY ONLY HEARD THE CLICK WHEN TURNING ON THE VENTX. THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT, HOWEVER, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY PER SOLTA MEDICAL REVIEWER DUE TO THE ABORTED PROCEDURE WITH THE PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128077 ↗