VIVEVE Console S VIVGE01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850794007132), received between Mar 2, 2020 and Jun 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJun 15, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO VIVEVE ON 18-MAY-2021 THAT A TREATMENT TIP DELAMINATED DURING A TREATMENT CAUSING AN ABRASION IN THE VAGINAL CANAL. PATIENT (PT) ORIGINALLY HAD A TREATMENT SCHEDULED FOR (B)(6) 2021 BUT TREATMENT WAS RESCHEDULED FOR (B)(6) 2021. PT RETURNED FOR THEIR RESCHEDULED TREATMENT ((B)(6) 2021) AND A NEW HANDPIECE (HP) WAS USED. THREE TIPS WERE USED DURING THIS TREATMENT, AND IT IS UNCLEAR FROM THE SITE WHICH OF THE THREE TIPS DELAMINATED. DURING USE OF ALL THREE TIPS THE PROVIDER FELT A FORCE FROM THE HP TOWARD THE PROVIDER. THE PROVIDER ALSO REPORTED AN ERROR APPEARED SAYING THE SYSTEM STOPPED DELIVERING RF/CRYOGEN. THE PT OPTED TO CONTINUE TREATMENT AFTER THIS OCCURRED WITH THE FIRST AND SECOND TIP. UPON EXAMINATION OF THE THIRD TIP, THE PROVIDER NOTICED A SMALL AMOUNT OF BLOOD. THE PROVIDER EXAMINED THE PT AND REPORTED AN ABRASION IN THE VAGINAL CANAL. THE PT WAS SENT HOME TO REST AND THE CLINIC PLANNED FOLLOW-UP WITH THE PT. THE NEXT DAY ((B)(6) 2021) THE PT REPORTED THAT THE DAY OF TREATMENT THEY HAD TO WEAR A TAMPON FOR BLEEDING AND NOW THEY WERE USING A PANTY LINER WITH LITTLE BLEEDING AND NO PAIN. ON (B)(6) 2021 THE PT CAME IN FOR A FOLLOW-UP. THE PT WAS DOING WE

  Patient problems: Abrasion

  MAUDE report 12001525 ↗
• InjuryMar 2, 2020No Apparent Adverse Event; No Apparent Adverse Event

  VIVEVE DOES NOT BELIEVE THIS MEETS THE CRITERIA FOR A REPORTABLE EVENT PER THE FDA MEDICAL DEVICE REPORTING FOR MANUFACTURERS, GUIDANCE ISSUED JULY 9, 2013. VIVEVE IS REPORTING FOR COMPLETENESS AS WE ARE AWARE THE PATIENT HAS VOLUNTARILY REPORTED. PATIENT REPORTED PAIN AND AN ASSUMED BURN. FOLLOWED UP WITH THE PHYSICIAN INCLUDED IRRITATION, NO EVIDENCE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 9776962 ↗