VASERRecalls & reported problems across all models

We found 6 models of VASER by Solta Medical in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Jan 15, 2019 and Jul 28, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Activation Failure” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VASER problems

VASER models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VASER 110-0037

  System, Suction, Lipoplasty
  16 reports
• VASER VHP

  System, Suction, Lipoplasty
  7 reports
• VASER 110-0022

  System, Suction, Lipoplasty
  4 reports
• VASER 110-0032

  System, Suction, Lipoplasty
  3 reports
• VASER 110-0021

  System, Suction, Lipoplasty
  1 report
• VASER 110-0036

  System, Suction, Lipoplasty
  1 report

Recent VASER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A user facility reported pain and a burn to the patient's abdomen during a Vaser procedure. The initial patient report notes that the individual experienced severe pain, a burning sensation, and a subsequent skin reaction described textually as a rash following the use of the medical device. Available images were reviewed by the medical reviewer. Visual inspection of the first image reveals a significant localized adverse skin reaction on the right abdominal and flank area. The affected region exhibits a sharply demarcated, erythematous, and edematous plaque covered with multiple tense, fluid-filled bullae of varying sizes. The underlying skin demonstrates a distinctive, regular textured grid pattern, suggesting direct contact or thermal/mechanical energy transfer from the device. In the second image, which appears to capture the same anatomical region at a different point in clinical management or healing, the large bullae seen previously are largely deflated or ruptured, leaving behind smaller residual fluid-filled vesicles. This image more prominently highlights the extensive, well-defined grid-like patterning across the hyperemic skin, along with substantial deep bruising and e

  Patient problems: Blister; Burn(s); Burning Sensation; Ecchymosis; Erythema; Pain; Rash

  MAUDE report 50060777 ↗
• 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 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN THAT ASSISTED WITH A VASERLIPO PROCEDURE REPORTED THAT A PATIENT DIED AT THE END OF A LIPO TRANSFER PROCEDURE DUE TO A PULMONARY EMBOLISM. IT WAS CONFIRMED THE COMPLICATION OCCURRED WHEN THE LIPOSUCTION TREATMENT WAS CONCLUDED DURING THE STITCHING PROCEDURE. THE NATURE OF THE EVENT WAS FAT THROMBOEMBOLISM. IT WAS REPORTED THAT THE PATIENT UNDERWENT CARDIOPULMONARY RESUSCITATION (CPR) FOR THE EVENT. THE AREAS OF THE BODY TREATED INCLUDE THE ABDOMEN, AND BACK, AS WELL AS A BUTTOCK LIPOTRANSFER. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE REPORTING PHYSICIAN DOES NOT BELIEVE THE PATIENT HAD UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE PATIENT HAD NOT HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA. AT THE TIME OF THE PROCEDURE, THE PATIENT WAS NOT USING ANY PRESCRIPTION OR NON-PRESCRIPTION MEDICATIONS, VITAMINS, HERBAL SUPPLEMENTS, OR TOPICAL PRODUCTS ON A REGULAR BASIS. THE SYSTEM WAS SUCCESSFULLY TESTED BEFORE THE PROCEDURE AND THE PROBE WAS ACTIVATED IN SALINE SOLUTION. THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE SYSTEM WAS TESTED. THE PROCEDURE WAS PERFORMED

  Patient problems: Fat embolism; Pulmonary Embolism

  MAUDE report 22134653 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMar 12, 2025Break; Activation Failure; Break; Activation Failure

  A USER FACILITY REPORTED THAT THE FOOT PEDAL OF THEIR VASER SYSTEM DID NOT WORK UPON PREPARATION FOR A TREATMENT. THE VASER FOOT PEDAL WAS PHYSICALLY DAMAGED. THERE WAS A DELAY OF MORE THAN SIXTY MINUTES WITH THE PATIENT UNDER GENERAL ANESTHESIA AND 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 21587680 ↗
• 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 ↗
• InjuryJan 7, 2025No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  A USER FACILITY REPORTED THAT THE VASERLIPO SYSTEM DISPLAY SCREEN WAS BLACK. HOWEVER, THE USER COULD HEAR THAT THE SYSTEM TURNED ON. THIS OCCURRED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR OVER 60 MINUTES AND RESULTED IN THE PROCEDURE BEING ABORTED. SINCE THE PROCEDURE WAS CANCELED AND THE DELAY UNDER GENERAL ANESTHESIA WAS NOTED ABOVE 60 MINUTES, THE CASE MEETS THE REPORTABILITY REQUIREMENTS AND IS DEEMED AS A SERIOUS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21094131 ↗
• 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 ↗
• InjuryNov 7, 2024Material Fragmentation; Blocked Connection; Material Fragmentation; Blocked Connection

  THIS CASE IS RELATED TO REPORT NUMBER: 3011423170-2024-00219. BOTH CASES ARE THE SAME PATIENT/EVENT AND CORRESPONDS TO THE VASER HANDPIECE. 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; No Consequences Or Impact To Patient

  MAUDE report 20631719 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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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