TRIO-CT® AS01135201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908133219), received between Aug 1, 2023 and Apr 12, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS TO HAVE A CT GUIDED G-TUBE PLACEMENT. DURING SCOUT FILM, AN AIR EMBOLUS WAS DETECTED IN THE RIGHT VENTRICLE. PATIENT WAS IMMEDIATELY REMOVED FROM THE CT TABLE AND THE G-TUBE PLACEMENT WAS DEFERRED. PATIENT WAS PLACED IN LEFT LATERAL DECUBITUS POSITION, PLACE ON 100% OXYGEN NONREBREATHER, AND ATTEMPTS MADE TO ASPIRATE THE AIR VIA THE PATIENT'S INDWELLING HEMODIALYSIS CATHETER. PATIENT BECAME INCREASINGLY HYPOXIC AND DETERIORATED WITH LOSS OF PULSE. CODE WAS IMMEDIATELY CALLED. PATIENT SURVIVED. MENTATION APPROPRIATE AND FOLLOWING COMMANDS.

  Patient problems: Cardiac Arrest; Embolism/Embolus

  MAUDE report 19098424 ↗
• MalfunctionAug 1, 2023Break; Break

  TRIPLE LUMEN VASCATH CATHETER WAS INSERTED BUT THE GUIDEWIRE WAS DIFFICULT TO REMOVE. THE GUIDEWIRE BROKE WHILE ATTEMPTING TO REMOVE. THE REST OF THE GUIDEWIRE CAME OUT WITH REMOVAL OF VASCATH. A SECOND VASCATH CATHETER WAS INSERTED AND THE SAME SCENARIO OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17433969 ↗