VCARE SMALL 60-6085-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405082068), received between Mar 14, 2016 and Mar 14, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2016Inadequacy of Device Shape and/or Size; Use of Device Problem

  DURING THE UTILIZATION OF A VCARE SERIES 300 VAGINAL-CERVICAL RETRACTOR-ELEVATOR SMALL SIZE, IT WAS REPORTED THAT THE PATIENT'S VAGINAL CANAL WAS VERY SMALL MAKING IT DIFFICULT FOR THE SURGEON TO INSERT THE FOAM OCCLUDER OF THE DEVICE INTO THE PATIENT. AS REPORTED, THE PHYSICIAN CONTINUED WITH THE DEVICE INSERTION NOTING THAT THE PATIENT'S VAGINAL OPENING WOULD MOST LIKELY TEAR WITH INSERTION OF THE VCARE 300 AND WITH OTHER VERSIONS OF MANIPULATORS FOR THE CUPS OF OTHER DEVICES WOULD ALSO BE TOO LARGE FOR AN ATROPHIED VAGINA DUE TO THE PATIENT'S AGE AND THE PATIENT BEING SO SMALL. THE FOAM OCCLUDER WAS SUCCESSFULLY PLACED ALTHOUGH A VAGINAL TEAR WAS NOTED FROM THE INSERTION. FURTHER INFORMATION RECEIVED STATES THAT THE PHYSICIAN SUTURED THE VAGINAL TEAR TO ASSIST IN THE HEALING OF THE TEAR. NO OTHER COMPLICATIONS WERE REPORTED IN REGARDS TO THE USE OF THE VCARE DEVICE AND THE PROCEDURE WAS OTHERWISE COMPLETED AS PLANNED.

  Patient problems: Injury

  MAUDE report 5497627 ↗