VASER 110-0032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850608002506), received between Jan 4, 2024 and Sep 3, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A VASER LIPO PROCEDURE A PATIENT EXPERIENCED A PROCEDURE DELAY OF GREATER THAN SIXTY MINUTES WHILE UNDER GENERAL ANESTHESIA DUE TO A SYSTEM SELF-TEST FAILURE. THE VASER SYSTEM WAS INOPERABLE WITH A RED TRIANGLE ERROR SIGNAL DURING THE TREATMENT, WHICH WAS A SURGERY ON BACK, FLANKS, ARMS, AND SUBMENTUM. A VENTX AND MICROAIRE PAL (POWER ASSISTED LIPO) WERE USED DURING THE PROCEDURE. NO PATIENT INJURY OCCURRED; HOWEVER, THE EVENT IS CONSIDERED A SERIOUS INJURY PER SOLTA PROCEDURE DUE TO THE PROCEDURE DELAY OVER 60 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER VASER LIPO DEVICE FROM A DIFFERENT CLINIC NEARBY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128708 ↗
• InjuryApr 10, 2024Activation Failure; Activation Failure

  A USER FACILITY REPORTED THAT THEY WERE UNABLE TO COMPLETE A VASER PROCEDURE ON A PATIENT BECAUSE THE VASER FOOTSWITCH STOPPED WORKING. THERE WAS A DELAY OF GREATER THAN 60 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE VASER DELIVERY ON THE FRONT OF THE PATIENT WAS COMPLETED BUT THE PROCEDURE HAD TO BE ABORTED PRIOR TO COMPLETION OF THE VASER PROCEDURE ON THE PATIENT¿S BACK. 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 AS WELL AS THE GREATER THAN ONE HOUR DELAY WHILE UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082942 ↗
• InjuryJan 4, 2024Excessive Heating; Excessive Heating

  A USER FACILITY REPORTED THAT A VASER PROBE WAS GETTING HOT DURING SURGERY AND THE PATIENT EXPERIENCED BURNS THE NEXT DAY FOLLOWING A VASER PROCEDURE. THE CUSTOMER PERFORMED A VASER SELF-TEST ON THE AMPLIFIER PRIOR TO THE PROCEDURE, IN WHICH THE DEVICE PASSED TESTING WITH NO ISSUES. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND THE TREATMENT AREA WAS PREPPED WITH 4-5L OF TUMESCENT FLUID. THE CUSTOMER UTILIZED A TOWEL BARRIER AND SKIN PORT TO PROTECT THE PATIENT¿S SKIN FROM UNINTENDED CONTACT WITH THE PROBE. VASER TREATMENT TO THE PATIENT WAS PERFORMED IN MULTIPLE AREAS INCLUDING THEIR FLANKS, BACK, INNER THIGHS, ARMS AND ABDOMEN. VASER ENERGY WAS DELIVERED TO THE PATIENT IN THE INJURY AREA FOR 6 MINUTES IN CONTINUOUS MODE WITH THE HIGHEST AMPLITUDE AT 50%. THE CUSTOMER DID KNOW ANY ENERGY LEVELS OR TIME FOR VASER DELIVERY IN OTHER AREAS. NO SYSTEM ERRORS HAD OCCURRED AND NOTHING UNUSUAL WAS NOTED DURING THE SURGERY. THE VASER PROBE HAD BEEN USED BEFORE ON OTHER PATIENTS PRIOR TO THIS PROCEDURE, AND THERE WAS NO VISIBLE PITTING OR WEAR. THE DAY FOLLOWING TREATMENT, THE PATIENT OBSERVED BURNS ON THE BILATERAL POSTERIOR OF THEIR ARM. THE PATIENT RECEIVED TREATMENT WITH RENUVION,

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Ulcer

  MAUDE report 18445694 ↗