VCARE MEDIUM 60-6085-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30653405061803), received between Dec 28, 2015 and Nov 19, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Break; Detachment of Device or Device Component

  UTERINE MANIPULATOR FELL APART WHILE BEING USED INSIDE PATIENT'S VAGINAL CAVITY DURING A ROBOTIC HYSTERECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592383 ↗
• MalfunctionMar 30, 2020Break

  UPON REMOVING THE CONMED MEDIUM V-CARE UTERINE MANIPULATING RETRACTOR FROM THE VAGINA, IT FELL APART. IT IS NOT MEANT TO DISASSEMBLE. THE CERVIX WITH UTERUS ATTACHED WAS SECURED TO THE GREEN SIZE 34MM CERVICAL CUP OF THE V-CARE AS PER PROCEDURE/ SURGICAL NORM. THIS GREEN CUP FELL APART FROM THE BLUE OBTURATOR/ MANIPULATOR. DEVICE WAS REMOVED FROM SERVICE AND ALL PIECES WERE OBTAINED. THE SPECIMEN WAS ALSO REMOVED SUCCESSFULLY WITH NO HARM TO THE PATIENT AND NO DELAY IN PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9896971 ↗
• MalfunctionMar 12, 2018Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(4) REPORTED A "DAMAGE" ON THE STERILE POUCH OF THIS 60-6085-201 DEVICE. THERE WAS NO PATIENT INVOLVEMENT AS THIS DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7331432 ↗
• InjuryMay 25, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED ON MEDWATCH FORM USER FACILITY # (B)(4), DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, "THE V-CARE UTERINE MANIPULATION DEVICE BALLOON AND GREEN CUP DETACHED FROM HANDLE INSIDE PATIENT. ALL DETACHED PARTS WERE RECOVERED AND THE PATIENT WAS NOT HARMED." THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE OR INJURY TO THE PATIENT. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591580 ↗
• InjuryMay 1, 2017Human Factors Issue; Human Factors Issue

  AS REPORTED TO CONMED ON MEDWATCH UF # (B)(4), "DURING A ROBOTIC ASSISTED HYSTERECTOMY, THE UTERINE MANIPULATOR WAS PLACED ON THE CERVIX PRIOR TO INCISION INTO THE ABDOMEN. AFTER INCISION INTO THE ABDOMEN, DURING THE PROCEDURE, AN OBJECT RESEMBLING A CONTACT LENS WAS OBSERVED IN THE ABDOMEN. IT WAS THEN NOTED THAT A PIECE OF THE BALLOON (THE SAME SIZE AND LIGHT BLUE COLOR) WAS MISSING FROM THE UTERINE MANIPULATOR. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT'S ABDOMEN." FOLLOW UP WITH THE USER FACILITY FOUND THERE WAS NO DELAY IN THE PROCEDURE AND NO PATIENT INJURY. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6535335 ↗
• MalfunctionMar 3, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED BY THE USER FACILITY: "THE VCARE WAS USED FOR A TOTAL LAPAROSCOPIC HYSTERECTOMY. WHEN REMOVING THE PRODUCT FROM THE PATIENT IT HAD FALLEN APART. THE BLUE TIP BALLOON AND THE GREEN CUP HAD BEEN LEFT IN THE PATIENT WHILST REMOVING THE SPECIMEN. THE SURGEON HAD TO REMOVE THE REMAINING PARTS MANUALLY." THERE WAS A 45 MINUTE DELAY AT THE END OF THE PROCEDURE, BUT IT WAS ABLE TO BE COMPLETED WITH NO FURTHER INCIDENT. FURTHER INFORMATION FROM THE FACILITY REVEALED THAT THE SURGEON DID NOT DEFLATE THE INTRAUTERINE BALLOON ON THE VCARE, AS SHE WAS TRYING TO USE THE VCARE TO REMOVE THE SPECIMEN. NO INJURY HAS BEEN REPORTED. THIS INCIDENT IS BEING REPORTED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6377916 ↗
• MalfunctionDec 14, 2016Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  CONMED RECEIVED A MEDWATCH REPORT FROM THE USER FACILITY REGARDING A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2016. ACCORDING TO THE REPORT "WHILE ATTEMPTING TO REMOVE THE UTERUS FROM THE PATIENT USING THE VCARE UTERINE MANIPULATOR, THE DEVICE CAME APART LEAVING PIECES OF THE DEVICE INSIDE THE PATIENT. TWO CUPS CAME OFF AND WERE RETRIEVED UNDER DIRECT VISUALIZATION OF THE LAPAROSCOPE VIA VAGINA. ALL PIECES WERE REMOVED FROM THE PATIENT AS WELL AS THE SPECIMEN. ALL PIECES WERE EVALUATED AND MATCHED BY STAFF." THERE WAS NO SURGICAL DELAY OR PATIENT INJURY AND THE PATIENT WAS DISCHARGED HOME WITH NO REPORTED COMPLICATIONS. FOLLOW UP WITH THE USER FACILITY CONFIRMED THAT THE DEVICE WAS DISCARDED AT THE HOSPITAL AND THUS NOT AVAILABLE FOR EVALUATION. THE DEVICE WAS NOT REPROCESSED AS WAS INDICATED ON THE MEDWATCH REPORT. TO DATE NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS INCIDENT. THIS REPORT IS BEING FILED AS A MALFUNCTION WITH THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6174054 ↗
• MalfunctionOct 19, 2016Burst Container or Vessel; Detachment Of Device Component

  THE USER FACILITY REPORTED THAT DURING USE OF A VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR WITH MEDIUM CERVICAL CUP IN A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE "BALLOON BURST AND DEVICE CAME APART" WHILE TRYING TO REMOVE THE UTERUS AND CERVIX FROM DOWN BELOW. AS REPORTED, THE DETACHED COMPONENTS WERE REMOVED FROM THE PATIENT AND VERIFIED THAT ALL PIECES WERE ACCOUNTED FOR. NO ALTERNATE DEVICE WAS USED AND THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6041341 ↗
• MalfunctionDec 28, 2015Detachment Of Device Component

  THE USER FACILITY REPORTED THAT DURING USE OF A VCARE UTERINE MANIPULATOR ON (B)(6) 2015, THE PATIENT UNDERWENT A LAVH (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY) PROCEDURE. AS REPORTED, AT THE MIDDLE OF THE PROCEDURE DURING THE COLPOTOMY, THE VCARE MANIPULATOR FELL APART. THE HANDLE OF THE DEVICE PULLED OUT OF THE PATIENT LEAVING THE CUPS AND BALLOON IN THE PATIENT'S PERITONEAL CAVITY. ALL PARTS WERE RETRIEVED MANUALLY BY THE SURGEON WITH NO SURGICAL DELAY REPORTED. FOLLOW-UP COMMUNICATION CONFIRMED THAT THE PROCEDURE WAS COMPLETED WITH A SECOND VCARE DEVICE WITH NO FURTHER INCIDENT AND/OR COMPLICATIONS, AND THERE WAS NO INJURY TO THE PATIENT. TO DATE, THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO CONMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5329852 ↗

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-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
• 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