VCARE EXTRA LARGE 60-6085-303Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405082099), received between Jun 9, 2016 and Jun 9, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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 16, 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.

• MalfunctionJun 9, 2016Unsealed Device Packaging

  THE END-USER MATERIALS RESOURCE NURSE REPORTED THAT DURING REVIEW OF INCOMING PRODUCTS, IT WAS DISCOVERED THERE WAS AN OPEN SEAL ON THE POUCH CONTAINING THE VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR WITH MEDIUM CERVICAL CUP. THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE OPEN SEAL WAS DISCOVERED DURING INSPECTION OF PRODUCT PRIOR TO CLINICAL PATIENT USE.

  Patient problems: No Patient Involvement

  MAUDE report 5708437 ↗