Venus Versa VE102407Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290016540383), received between Aug 8, 2019 and Apr 4, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  15, FEBRUARY 2023: EMAIL SENT TO CLINICAL REPORTING A BURN FROM HAIR REMOVAL TREATMENT. TRAINER EMAILED TO GATHER ADDITIONAL INFORMATION. IN AN EFFORT TO GET MORE INFORMATION ABOUT THE SEVERITY OF THE BURN ON THE LEGS, TWO EMAIL CORRESPONDENCE WAS SENT ON THE 15 FEB 2023 AND 21 FEB 2023, BUT NO AVAIL. ONE PHONE CALL MADE TRYING TO GET A HOLD OF THE CLINIC, CALL KEEPS DROPPING; NO ANSWER.

  Patient problems: Burn(s)

  MAUDE report 16673531 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 THE PATIENT HAD 3RD TREATMENT WITH VENUS VERSA SYSTEM USING DIAMOND POLAR APPLICATOR, ON HER FACE. THE INITIAL DIAGNOSIS OF THE PATIENTS THAT EVENING WAS STROKE. THE FINAL DIAGNOSIS IS GENETIC BLOOD DISORDER. ACCORDING TO MD, THE INCIDENT MOST LIKELY HAPPENED BECAUSE OF HER PREVIOUS MEDICAL HISTORY. POST INVESTIGATION, ACCORDING TO THE MD, THE PATIENT DID NOT SUFFER FROM STROKE AND NO LATERAL INJURIES(AS WAS INITIALLY PERCEIVED). IT WAS DISCOVERED THAT PATIENT HAS A GENETIC BLOOD CONDITION THAT MAKES HER BLOOD TOO THICK , THE INCIDENT ACCORDINGLY MOST LIKELY HAPPENED BECAUSE OF HER PREVIOUS MEDICAL HISTORY (THROMBOPHLEBITIS,WAS PRESCRIBED ANTICOAGULANT, AND LATER SHE DISCONTINUE ANTICOAGULANTS; REASON FOR WHICH IS UNKNOWN). THE PATIENT SUFFERED PROLONG THROMBOPHLEBITIS IN THE PAST AND HAD RELATED SURGERY ON HER LEG VEINS 3 MONTHS BEFORE THE TREATMENT. PATIENT SUFFERED OVERWEIGHT, 75 LB ABOVE THE AVERAGE. THE PATIENT WAS INITIALLY HOSPITALIZED AND COULD NOT SPEAK, AND THEN HER CONDITION IMPROVED AND SHE RETURNED HOME. THE CLINIC KNEW THAT THE PATIENT USED TO TAKE ANTICOAGULANTS MEDICATIONS. VENUS VERSA SYSTEM TREATMENT PARAMETERS: TOTAL TREATMENT DURATION: 30 MIN: 20

  Patient problems: Hemorrhage, Subdural

  MAUDE report 8872760 ↗