VersaOne RC11STSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521784048), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K201805); 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.

Recalls naming this device

1. Mar 22, 2023Open, Classified

   There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.

   Z-1464-2023 · Root cause: Process control · FDA record ↗

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.

• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE DEVICE COULD NOT BE OPENED FOR STERILIZATION OR FOR CHANGING THE SEAL, AND THE CANNULA BROKE. ALL PORTS WERE AFFECTED. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716771 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201805. One submission often covers many models, so check the product and lot details in each record.

• Z-1463-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
• Z-1465-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS