VCARE LARGE 60-6085-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405061810), received between Aug 1, 2017 and Aug 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K071907); they may or may not involve this specific model.

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.

• MalfunctionAug 1, 2017Detachment Of Device Component; Detachment Of Device Component

  A USER FACILITY REPORTED A 60-6085-202 VCARE DEVICE DROPPED TO BITS. THE DEVICE COMPONENTS WERE REPORTED TO DETACH FROM ONE ANOTHER BUT THE UTERUS AND UPPER CUP STAYED CONNECTED. DESPITE SEVERAL ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING THE TERM "DROPPED TO BITS", NO CLARIFICATION HAS BEEN PROVIDED. THE PROCEDURE WAS COMPLETED AS PLANNED. NO PATIENT INJURY WAS REPORTED AND ALL DETACHED COMPONENTS WERE RETRIEVED. THIS DEVICE WAS DISCARDED BY THE USER FACILITY; THEREFORE, A SPECIFIC FAILURE MODE/ROOT CAUSE IS UNABLE TO BE DETERMINED. ALTHOUGH THE COMPLAINT IS UNABLE TO BE VERIFIED/CONFIRMED, PHOTOS SHOW THE DEVICE IN MULTIPLE PIECES. THE CERVICAL CUP AND VAGINAL CONE HAS COMPLETELY DETACHED FROM THE MANIPULATOR TUBE. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY IF RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6758142 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071907. One submission often covers many models, so check the product and lot details in each record.

• Z-1520-2011 · Feb 2, 2011 · Terminated
  VCare Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5" x 12"
• Z-0177-2009 · Sep 8, 2008 · Terminated
  VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60-6085-002. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE
• Z-0175-2009 · Sep 8, 2008 · Terminated
  VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-000. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VC
• Z-0176-2009 · Sep 8, 2008 · Terminated
  VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60-6085-001. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE Re