VASER VHPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850608002551), received between Mar 12, 2024 and Jun 4, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Activation Failure” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2025Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure

  A USER FACILITY REPORTED THAT THERE WAS AN ISSUE WITH THE VASER HANDPIECE DURING SURGERY. THE USER WAS ASKED TO PERFORM THE VASER SELF TEST AND IT PASSED. A NEW PROBE WAS CONNECTED AND THE OPERATIONAL VHP TEST WAS PERFORMED, AND IT WORKED IN A RECIPIENT WITH WATER. HOWEVER, WHEN THE USER STARTED AGAIN WITH THE PATIENT, IT FAILED. THE CABLE AND CONNECTORS WERE INSPECTED AND THE USER CONFIRMED THEY LOOKED FINE, BUT WHEN ASKED THEM TO STRESS THE HANDPIECE CABLE, IT BEGAN FAILING AND THE CONNECTOR SEEMED TO DISCONNECT EASILY FROM THE CONSOLE. AS THERE WAS NO BACKUP HANDPIECE AVAILABLE, THE PROCEDURE WAS ABORTED. THIS RESULTED IN THE PATIENT BEING UNDER GENERAL ANESTHESIA WITHOUT CLINICAL BENEFIT, WHICH MAY POSE A RISK OF HARM. THEREFORE, THE EVENT IS CONSIDERED A SERIOUS INCIDENT DUE TO THE UNNECESSARY EXPOSURE TO GENERAL ANESTHESIA AND THE INTERRUPTION OF THE PLANNED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145176 ↗
• InjuryMay 1, 2025Activation Failure; Activation Failure

  A USER FACILITY CONTACTED SOLTA DURING A VASERLIPO PROCEDURE AND REPORTED THAT THE WIRELESS FOOTSWITCH STOPPED COMMUNICATING TO THE VASER AND THEY WERE UNABLE TO DELIVER ULTRASOUND ENERGY. THE CUSTOMER HAD CHANGED THE BATTERIES IN THE WIRELESS FOOTSWITCH AND TRIED TO USE A WIRED FOOTSWITCH CONNECTED DIRECTLY TO THE AMPLIFIER, HOWEVER THEY WERE UNABLE TO GET THE VASER AMPLIFIER TO DELIVER ENERGY. THROUGH FURTHER TROUBLESHOOTING, SOLTA FOUND THE VASER WAS NOT RESPONDING DUE TO THE VASER HANDPIECE. THE CUSTOMER DID NOT HAVE AN ADDITIONAL HANDPIECE TO USE. THIS ISSUE CAUSED A DELAY LONGER THAN 60 MINUTES WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE SURGERY WAS COMPLETED WITHOUT USE OF THE VASER AMPLIFIER. SOLTA HAS MADE ATTEMPTS TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT, BUT THEY HAVE BEEN UNSUCCESSFUL AND IT APPEARS NO RESPONSE WILL BE FORTHCOMING. 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 PROLONGED PROCEDURE GREATER THAN ONE HOUR WHILE UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944969 ↗
• InjuryNov 7, 2024Material Fragmentation; Blocked Connection; Material Fragmentation; Blocked Connection

  THIS CASE IS RELATED TO REPORT NUMBER: 3011423170-2024-00218. BOTH CASES ARE THE SAME PATIENT/ EVENT AND CORRESPONDS TO THE VASERLIPO SYSTEM. A USER FACILITY REPORTED THAT THEY HAD PULLED THE HANDPIECE CABLE DURING SURGERY AND THE VASER HANDPIECE PINS BROKE OFF THE HANDPIECE CONNECTOR AND GOT STUCK INSIDE THE VASER AMPLIFIER HANDPIECE CONNECTION PORT. THE CUSTOMER WAS UNABLE TO CONNECT ANOTHER VASER HANDPIECE DUE TO THE STUCK PINS. THE CUSTOMER REPORTEDLY DID NOT HAVE TO ABORT THE PROCEDURE AND USED CONVENTIONAL LIPOSUCTION TO FINISH THE SURGERY. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE ISSUE OCCURRED, WHICH RESULTED IN A DELAY GREATER THAN 60 MINUTES. FURTHER INFORMATION HAS BEEN REQUESTED HOWEVER THE CUSTOMER DID NOT PROVIDE ANY FURTHER DETAILS OF THE EVENT. THERE WERE NO REPORTED HEALTH CONSEQUENCES TO THE PATIENT, HOWEVER, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY PER SOLTA MEDICAL REVIEWER DUE TO THE DELAY WHILE UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635905 ↗
• InjuryOct 3, 2024Communication or Transmission Problem; Communication or Transmission Problem

  A USER FACILITY REPORTED THAT THE THE VASER STOPPED FUNCTIONING IN THE MIDDLE OF THE SURGERY WHICH RESULTED IN AN ABORTED PROCEDURE WITH THE PATIENT UNDER GENERAL ANESTHESIA MORE THAN 60 MINUTES. THE PHYSICIAN TRIED WIRELESS FOOT-PEDALS AS WELL AS A WIRED CABLE TO NO AVAIL. THE USER FACILITY ALSO REPORTED THE HANDPIECE WAS INOPERABLE. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE. THE TREATMENT WAS CARRIED OUT NORMALLY ON THE PATIENT'S TORSO, BUT WHEN CONTINUING ONTO THE BACK, THE HANDPIECE STOPPED WORKING. THE TOTAL TIME OF THE VASER DELIVERY WAS 20 MINUTES. THE TREATMENT WAS NOT ABLE TO COMPLETED WITH ANOTHER SYSTEM OR DIFFERENT METHOD. THE PROCEDURE WAS CANCELED AND THE DELAY UNDER GENERAL ANESTHESIA WAS NOTED ABOVE 60 MINUTES; THEREFORE, THE CASE MEETS THE REPORTABILITY REQUIREMENTS AND IS DEEMED AS A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364903 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BURNS TO THE RIGHT THIGH DURING A VASER LIPO TREATMENT. THE PATIENT¿S BURNS WERE TREATED WITH SILVADENE OINTMENT AND THE PATIENT IS BEING SEEN BY A WOUND DOCTOR. PERMANENT DAMAGE AND SCARRING IS EXPECTED. AVAILABLE PICTURES WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER. A LARGE WOUND IS VISIBLE ON RIGHT THIGH ABOVE THE KNEE. PART OF THE WOUND IS STILL OPEN. THERE ARE SMALLER BURNED AREAS VISIBLE ON UPPER THIGH WITH BLISTERS MAINLY ON RIGHT THIGH. THE VASER LIPO TREATMENT WAS PERFORMED AT THE SAME TIME AS A J PLASMA TREATMENT. THE PATIENT HAD NO PRIOR HISTORY OF AESTHETIC TREATMENTS TO THE AFFECTED AREA. THE PROVIDER REPORTEDLY TESTED THE VASER LIPO DEVICE WHEN THE PATIENT WAS UNDER ANESTHESIA. WHEN THE ISSUE OCCURRED, THE SYSTEM WAS IN VASER MODE AT 60% AMPLITUDE. NO SYSTEM ERRORS WERE OBSERVED DURING THE TREATMENT, AND NOTHING ATYPICAL WAS OBSERVED DURING THE TREATMENT. THE TOTAL VASER DELIVERY TIME WAS FIVE MINUTES PER THIGH, WITH 1200ML TUMESCENT FLUID USED ON EACH THIGH. APPROXIMATELY 600 CC OF LIPO ASPIRATE WAS REMOVED FROM EACH TREATMENT AREA. A VENTX WAS USED DURING THE PROCEDURE WITH NO PROBLEMS NOTED. A MICROAIR POWER ASSISTED LIPO

  Patient problems: Blister; Burn(s); Scar Tissue

  MAUDE report 19566343 ↗
• InjuryJun 11, 2024Activation Failure; Activation Failure

  A USER FACILITY REPORTED THAT THEIR VASER HANDPIECE WAS NOT WORKING WHILE CONNECTED TO THE VASER AND THE ALARM OF THE DEVICE WAS ON. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE ISSUE OCCURRED, AND THE TREATMENT HAD TO BE CANCELED. THE VASER SYSTEM AND HANDPIECES WERE USED THAT DAY FOR A PREVIOUS PROCEDURE WITH NO ISSUE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512710 ↗
• InjuryMar 12, 2024Break; Connection Problem; Break; Connection Problem

  THIS REPORT IS RELATED TO 3011423170-2024-00130 (VASERLIPO SYSTEM) BOTH INVOLVING THE SAME PATIENT. THIS REPORT IS ASSOCIATED WITH THE VASER HAND PIECE. A USER FACILITY REPORTED THAT THE VASER HANDPIECE RECEPTACLE BROKE DURING A VASERLIPO SURGERY. THE TREATMENT WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. AN AVAILABLE VIDEO WAS RECEIVED, AND IT DEMONSTRATES THAT THE HANDPIECE RECEPTACLE IS DAMAGED. FURTHER INFORMATION HAS BEEN REQUESTED AND THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886559 ↗