VersaOne UNVCA5STBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521809031), received between Aug 22, 2024 and Feb 4, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY THE 5 MM BALLOON PORT BALLOON POPPED DURING SURGERY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256801 ↗
• MalfunctionNov 27, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC JEJUNOSTOMY TUBE INSERTION, AT THE END OF THE CASE, THE BALLOON POPPED. AS THE SURGEON REALIZED THE ISSUE AT THE END OF THE PROCEDURE, NO FURTHER ACTION WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23667622 ↗
• MalfunctionSep 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE BALLOON ON THE TROCAR DEFLATED AND THE SEAL WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066160 ↗
• MalfunctionJan 29, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NON-CANCER GYNECOLOGY (GYN) PROCEDURE, THE DEVICE HAS A SEAL DAMAGE. IT WAS ALSO NOTED THAT THE BALLOON TROCAR LOST INFLATION. ANOTHER TROCAR WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269705 ↗
• MalfunctionJan 28, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NON-CANCER GYNECOLOGICAL PROCEDURE, THE BALLOON ON THE TROCAR WOULD NOT INFLATE OR HOLD AIR. ADDITIONALLY, A DAMAGED SEAL WAS NOTED ON THE DEVICE. THE ISSUE WAS RESOLVED BY REPLACING THE TROCAR WITH ANOTHER 5 MILLIMETER TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252512 ↗
• MalfunctionAug 22, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, AT THE BEGINNING OF THE CASE, THERE WAS A DAMAGED SEAL AND WAS NOT COMPLETE. IT WAS NOTED THAT THE BALLOON INFLATED AND LEAKED AIR AND WENT LIMP SO IT WAS NOT HOLDING THE TROCAR IN PLACE ANYMORE. THE USER CARRIED ON WITH THE PROCEDURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025358 ↗