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VASER 110-0037Recalls & reported problems

Solta Medical · VASER PRO AMPLIFIER, 220V · Class 2

Adverse event reports
16
Deaths reported
0
Injuries reported
16
Recalls naming it
0

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00850608002537), received between Jan 15, 2019 and Jul 28, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Break” (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.

Reports received per month

Nov 2023: 5 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem12
  • Break2
  • Activation Failure1
  • Blocked Connection1
  • Communication or Transmission Problem1
  • Connection Problem1
  • Material Fragmentation1
  • No Display/Image1

Patient problems

  • Burn(s)10
  • Scar Tissue5
  • No Clinical Signs, Symptoms or Conditions4
  • Blister1
  • Burning Sensation1
  • Ecchymosis1
  • Erythema1
  • Fat embolism1

Recent adverse event reports

The 16 most recent of 16 reports, 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 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 ↗
  • 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 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: 3011423170-2024-00219. 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 ↗
  • InjuryMar 12, 2024Break; Connection Problem; Break; Connection Problem

    THIS REPORT IS RELATED TO 3011423170-2024-00131 (VASER HANDPIECE) BOTH INVOLVING THE SAME PATIENT. THIS REPORT IS ASSOCIATED WITH THE VASERLIPO SYSTEM. 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 18886577 ↗
  • InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED BURNS TO THE ABDOMEN 2 DAYS POST VASERLIPO TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. ONE PICTURE (PROBABLY PRIOR TO SURGERY) SHOWS NO INJURY WHILE THE OTHER PICTURE SHOWS A BURNED AREA ON THE ABDOMEN, MOSTLY ON EPIGASTRIC REGION. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDES BURN CREAMS AND OZONE TREATMENT. IT IS REPORTED THAT THE PATIENT IS STILL UNDER TREATMENT AND THAT PERMANENT DAMAGE/ SCARRING IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE AND THE VASER PASSED THE SELF TEST. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 10%. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 6 MIN MAXIMUM WITH 1 MIN PER AREA. 6000 ML TO 8000 ML TUMESCENT FLUID WAS USED WITH ABOUT 2000 ML TO 3000 ML PER AREA. 5 L OF LIPO ASPIRATE WAS REMOVED AFTER

    Patient problems: Burn(s)

    MAUDE report 18277410 ↗
  • InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED BURNS TO THE ABDOMEN 2 DAYS POST VASERLIPO TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. ONE PICTURE (PROBABLY PRIOR TO SURGERY) SHOWS NO INJURY WHILE THE OTHER PICTURE SHOWS A BURNED AREA ON THE ABDOMEN, MOSTLY ON EPIGASTRIC REGION. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDES BURN CREAMS AND OZONE TREATMENT. IT IS REPORTED THAT THE PATIENT IS STILL UNDER TREATMENT AND THAT PERMANENT DAMAGE/ SCARRING IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED)WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE AND THE VASER PASSED THE SELF TEST. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 10%. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 6 MIN MAXIMUM WITH 1 MIN PER AREA. 6000 ML TO 8000 ML TUMESCENT FLUID WAS USED WITH ABOUT 2000 ML TO 3000 ML PER AREA. 5 L OF LIPO ASPIRATE WAS REMOVED A

    Patient problems: Burn(s)

    MAUDE report 18275186 ↗
  • InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED BURNS 2 DAYS POST VASERLIPO TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. BURNED AREAS ARE VISIBLE ON ABDOMINAL AREAS, MOSTLY ON EPIGASTRIC AND HYPOGASTRIC REGIONS. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDES BURN CREAMS AND OZONE TREATMENT. IT IS REPORTED THAT THE PATIENT IS STILL UNDER TREATMENT AND THAT PERMANENT DAMAGE/ SCARRING IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE AND THE VASER PASSED THE SELF-TEST. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 10%. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 6 MIN MAXIMUM WITH 1 MIN PER AREA. 6000 ML TO 8000 ML TUMESCENT FLUID WAS USED WITH ABOUT 2000 ML TO 3000 ML PER AREA. 5 L OF LIPO ASPIRATE WAS REMOVED AFTER FRAGMENTATION. THE PROCEDURE WAS COMPLETED USING THE VASER. IT IS NO

    Patient problems: Burn(s); Scar Tissue

    MAUDE report 18173120 ↗
  • InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED BURNS TO THE ABDOMEN 2 DAYS POST VASERLIPO TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. BURNED AREAS ARE VISIBLE ON ABDOMINAL AND PELVIC AREAS. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDES BURN CREAMS AND OZONE TREATMENT. IT IS REPORTED THAT THE PATIENT IS STILL UNDER TREATMENT AND THAT PERMANENT DAMAGE/ SCARRING IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE AND THE VASER PASSED THE SELF-TEST. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 10%. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 6 MIN MAXIMUM WITH 1 MIN PER AREA. 6000 ML TO 8000 ML TUMESCENT FLUID WAS USED WITH ABOUT 2000 ML TO 3000 ML PER AREA. 5 L OF LIPO ASPIRATE WAS REMOVED AFTER FRAGMENTATION. THE PROCEDURE WAS COMPLETED USING THE VASER. IT IS NOTED THAT A POWER ASS

    Patient problems: Burn(s); Scar Tissue

    MAUDE report 18173094 ↗
  • InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED BURNS 2 DAYS POST VASERLIPO TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. BURNED AREAS ARE VISIBLE ON ABDOMINAL AREAS, MOSTLY EPIGASTRIC AREA AND LOWER CHEST. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDES BURN CREAMS AND OZONE TREATMENT. IT IS REPORTED THAT THE PATIENT IS STILL UNDER TREATMENT AND THAT PERMANENT DAMAGE/ SCARRING IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE AND THE VASER PASSED THE SELF-TEST. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 10%. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 6 MIN MAXIMUM WITH 1 MIN PER AREA. 6000 ML TO 8000 ML TUMESCENT FLUID WAS USED WITH ABOUT 2000 ML TO 3000 ML PER AREA. 5 L OF LIPO ASPIRATE WAS REMOVED AFTER FRAGMENTATION. THE PROCEDURE WAS COMPLETED USING THE VASER. IT IS NOTED TH

    Patient problems: Burn(s); Scar Tissue

    MAUDE report 18173076 ↗
  • InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED BURNS 2 DAYS POST VASERLIPO TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. BURNED AREAS ARE VISIBLE ON ALL ABDOMEN, PELVIC AND LOWER CHEST AREAS. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDES BURN CREAMS AND OZONE TREATMENT. IT IS REPORTED THAT THE PATIENT IS STILL UNDER TREATMENT AND THAT PERMANENT DAMAGE/ SCARRING IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE AND THE VASER PASSED THE SELF-TEST. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 10%. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 6 MIN MAXIMUM WITH 1 MIN PER AREA. 6000 ML TO 8000 ML TUMESCENT FLUID WAS USED WITH ABOUT 2000 ML TO 3000 ML PER AREA. 5 L OF LIPO ASPIRATE WAS REMOVED AFTER FRAGMENTATION. THE PROCEDURE WAS COMPLETED USING THE VASER. IT IS NOTED THAT A POWER ASS

    Patient problems: Burn(s); Scar Tissue

    MAUDE report 18173018 ↗
  • InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED BURNS 2 DAYS POST VASERLIPO TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. CRUSTED AREAS ARE VISIBLE ON THE PATIENT'S BACK. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDES BURN CREAMS AND OZONE TREATMENT. IT IS REPORTED THAT THE PATIENT IS STILL UNDER TREATMENT AND THAT PERMANENT DAMAGE/ SCARRING IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE AND THE VASER PASSED THE SELF-TEST. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 10%. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 6 MIN MAXIMUM WITH 1 MIN PER AREA. 6000 ML TO 8000 ML TUMESCENT FLUID WAS USED WITH ABOUT 2000 ML TO 3000 ML PER AREA. 5 L OF LIPO ASPIRATE WAS REMOVED AFTER FRAGMENTATION. THE PROCEDURE WAS COMPLETED USING THE VASER. IT IS NOTED THAT A POWER ASSISTED LIPO DEVICE WAS

    Patient problems: Burn(s); Scar Tissue

    MAUDE report 18173001 ↗
  • InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED A BURN FOLLOWING SURGERY WITH A VASER PRO AMPLIFIER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Burn(s)

    MAUDE report 15654888 ↗
  • InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED A BURN FOLLOWING SURGERY WITH A VASER PRO AMPLIFIER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Burn(s)

    MAUDE report 15654884 ↗
  • InjuryJan 15, 2019Nonstandard Device; Adverse Event Without Identified Device or Use Problem

    I AM A PLASTIC SURGEON AND ON (B)(6) 2018 I HAD A CASE OF A YOUNG LADY WHO ASKED ME TO REMOVE LOCALIZE FAT FROM THE LATERAL PART OF THE THIGHS AND THE LATERAL PART OF THE ABDOMEN. I USED THE VASERLIPO DEVICE AND THE PARAMETERS THAT I USED WERE THE FOLLOWING: THE WETTING SOLUTION WAS OF ABOUT 600ML FOR EACH SIDE AT THE LATERAL THIGHS; AT THE SAME AREAS THE PROBE OF THREE RINGS; THE SETTINGS WERE AT 80%. I DELIVERED ENERGY FOR 5 MINS AND 43 SECONDS TO THE RIGHT SIDE AND 5 MIN TO THE LEFT SIDE. THE ENERGY WAS ONLY DELIVERED TO THE DEEP LAYER OF THE FAT. SUPERFICIAL LAYERS WERE LEFT UNTOUCHED. NO MALFUNCTION INDICATION APPEARED ON THE VASER DEVICE. I DID NOT DO SUPERFICIAL LIPOLYSIS AT ALL, I HAVE FOLLOWED ALL THE GUIDELINES THAT THE COMPANY OF THE VASER SUGGESTS. AFTER THIS TREATMENT, NO SIGNS OF ANY PROBLEM APPEARED AND THE PT HAS BEEN DISCHARGED. A FEW DAYS LATER, I SAW THAT IN THE AREA A VERY SEVERE BURN WAS PROVOKED. THE BURN WAS INVOLVING THE WHOLE THICKNESS OF THE SKIN AND FAT AS WELL, UP TO THE UNDERLINE MUSCLES. IT HAS HAPPENED TO BOTH AREAS OF THE LATERAL THIGHS AND IN A SMALLER GRADE AT THE LATERAL PART OF THE ABDOMEN. THE BURNED AREA WAS EXTENDED TO THE LIMITS AND SOMETIMES

    Patient problems: Full thickness (Third Degree) Burn

    MAUDE report 8248911 ↗

Other System, Suction, Lipoplasty devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.