VCARERecalls & reported problems across all models

We found 4 models of VCARE by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 285 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2017 and Aug 24, 2026 — classified as 24 injuries, 261 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (92 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VCARE problems

VCARE models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VCARE 60-6085-201A

  Cannula, manipulator/injector, uterine
  198 reports
• VCARE 60-6085-202A

  Cannula, manipulator/injector, uterine
  46 reports
• VCARE 60-6085-200A

  Cannula, manipulator/injector, uterine
  40 reports
• VCARE 60-6085-203A

  Cannula, manipulator/injector, uterine
  1 report

Recent VCARE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50404507 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50343654 ↗
• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50297901 ↗
• MalfunctionAug 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50273397 ↗
• MalfunctionAug 14, 2026Loose or Intermittent Connection

  A sales representative reported on behalf of a customer that the device, 60-6085-200A, SMALL,UTERINE MANIPULATOR,VAGINAL, was used in an unnamed procedure on(B)(6) 2026, and ¿the screw came loose. Instead of opening a new item the nurse held the unit in place for the remainder of the surgery. There was no delay our patient injury.¿. The procedure was completed. There was no report of medical/surgical intervention, or extended hospitalization for the patient. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260235 ↗
• MalfunctionAug 14, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252074 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225211 ↗
• MalfunctionAug 11, 2026Material Fragmentation

  The sales representative reported on behalf of the customer that the MEDIUM,UTERINE MANIPULATORwas being used on16JUL26 during a Robotic Assisted Hysterectomy procedure when it was reported ¿the VCARE completely broke apart inside of the patient.¿. Further assessment questioning found that ¿the VCare fell apart in the patient and had to be retrieved. The patient was not injured, and they were able to complete the procedure.¿. There was no report of injury, medical intervention or extended hospitalization for the patient or user. This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211744 ↗
• InjuryJul 29, 2026Unstable

  A sales representative reported on behalf of a customer that the devic, 60-6085-201A, MEDIUM, UTERINE MANIPULATOR, was used in a Robotic Assisted Total Laparoscopic Hysterectomy, Bilateral Salpingectomy, Cystoscopy procedure on (b)(6) 2026, and experienced ¿screw failures on the device." Further assessment found "Assisted on a robotic hysterectomy and the Vcare uterine manipulator ¿malfunctioned¿ - the part of the manipulator that locks down the cup has failed in at least 2 cases and was told by the OR techs there have been similar issues with the device in other surgeries. The white screw loosens and the manipulator advanced and led to uterine perforation and can only be ratcheted down tightly with an instrument." There was no report of medical/surgical intervention, or extended hospitalization for the patient.This report is being raised due to the reported injury of uterine perforation.

  Patient problems: Uterine Perforation

  MAUDE report 50068392 ↗
• MalfunctionJul 29, 2026Unstable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067659 ↗
• MalfunctionJul 28, 2026Unstable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060125 ↗
• MalfunctionJul 28, 2026Unstable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059897 ↗
• MalfunctionJul 22, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25903451 ↗
• MalfunctionJun 30, 2026Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DEVICE, 060-6085-201A, MEDIUM, UTERINE MANIPULATOR, WAS USED IN A ROBOTIC HYSTERECTOMY PROCEDURE ON APPROXIMATELY 04JUN26, AND ¿VCARE BREAKING DURING A CASE ON 6-4¿. IT WAS A DV5 ROBOTIC CASE WITH DR. "[¿]", "[¿]" PA MANIPULATING. HYSTERECTOMY. NO HARM TO PT. I THINK IT WAS PRETTY EARLY ON IN THE CASE THAT IT SNAPPED. IT WAS NOT A LARGE UTERUS, IF I REMEMBER CORRECTLY¿. FURTHER ASSESSMENT FOUND THE "THE WHITE SCREW BROKE OFF AND WAS 'MISALIGNED' PER THE STAFF. THE SCREW FELL ON THE FLOOR AND WAS THROWN AWAY.". THE DEVICE DID NOT FRAGMENT, AND NO COMPONENTS DETACHED INSIDE THE PATIENT. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663750 ↗
• InjuryJun 11, 2026Device Dislodged or Dislocated

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-6085-201A, MEDIUM,UTERINE MANIPULATOR WAS BEING USED ON 22MAY26 AND ¿¿TIP IS SLIPPING. SLIPPING TIP IS RESULTING IN PERFORATED UTERUS.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "THE WHITE TAB ON THE SIDE OF THE VCARE SHAFT DOESN'T LOCK DOWN. THAT THE VCARE MOVES (DOESN'T STAY LOCKED ON THE BLUE OCCLUDER), SO THE SHAFT OF VCARE GOES FURTHER THAN THEY WANT INTO THE PATIENT AND THIS IS CAUSING THE PERFORATED UTERUS. THIS WAS DURING A ROBOTIC HYSTERECTOMY, YES, THE SURGERY WAS COMPLETED, NO DELAYS. PATIENT WAS FINE, THEY WERE ABLE TO COMPLETE THE PROCEDURE." THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PERFORATED UTERUS.

  Patient problems: Uterine Perforation

  MAUDE report 25475129 ↗

Other Conmed Corporation products

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• UltraClean8 models · 84 reports
• UNIVERSAL PLUS9 models · 68 reports
• Y-KNOT14 models · 65 reports
• GENESYS CrossFT, Hi-Fi4 models · 4 reports · 1 recall