ORIGINS 820-FNBU2030LLNRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816995025733), received between Jun 20, 2025 and Jun 20, 2025 — classified as 1 injury.

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

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.

• InjuryJun 20, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED TO A DISTRIBUTOR THAT THE VENTX CANNULA SEPARATED FROM THE BASE. THE EVENT OCCURRED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. AS A DIRECT CONSEQUENCE TO THE BROKEN CANNULA, THE PROCEDURE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE SURGICAL INTERVENTION WAS ULTIMATELY COMPLETED USING A REPLACEMENT CANNULA. IN ACCORDANCE WITH INTERNAL SAFETY GUIDELINES, THE CASE HAS BEEN ASSESSED AS SERIOUS DUE TO THE EXTENDED DURATION OF GENERAL ANESTHESIA REQUIRED AS A DIRECT CONSEQUENCE OF THE BROKEN CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298079 ↗