TRACOE twist REF 301-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324032815), received between Mar 26, 2026 and Mar 26, 2026 — classified as 1 death.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 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.

• DeathMar 26, 2026Use of Device Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A SUPPLY OF WARD STOCK TRACHEOSTOMY TUBES. UNFORTUNATELY, A CUFFED SIZE 7 TUBE WAS SENT HOME WHEN THE PATIENT REQUIRED AN UNCUFFED SIZE 7 TUBE. WHEN THE PATIENT REQUIRED AN UNEXPECTED TRACHEOSTOMY TUBE CHANGE, THE NURSE OPENED THE CUFFED SIZE 7 TUBE AND REALIZED A SMALLER SIZE CUFFED TUBE WAS NEEDED. A SIZE 6 TRACHEOSTOMY TUBE WAS THE ONLY ONE AVAILABLE. THE SIZE 6 DID NOT SIT COMFORTABLY AND WAS THOUGHT TO CAUSE OVER GRANULATION OF SURROUNDING TISSUE AND ON NEXT CHANGE THE STOMA STARTED TO BLEED, AND THE TUBE WAS NOT ABLE TO BE REINSERTED. THIS NECESSITATED AN URGENT TRANSFER TO A HOSPITAL. DURING AMBULANCE TRANSPORT, THE PATIENT SUFFERED A RESPIRATORY ARREST, AND FOLLOWING STABILIZATION IN THE EMERGENCY DEPARTMENT, THE PATIENT WAS TRANSFERRED TO CRITICAL CARE. DESPITE THESE EFFORTS, IT WAS DETERMINED THAT THE PATIENT HAD LIKELY SUSTAINED A SEVERE HYPOXIC BRAIN INJURY AND PASSED AWAY AFTERWARDS. RESPONSE FROM HOSPITAL ON (B)(6) 2026: THANK YOU FOR RESPONDING- I NEED TO CLARIFY- THIS IS NOT AN ISSUE WITH THE FAULTY TUBE. THE PATIENT WAS KNOWINGLY GIVEN THE INCORRECT TUBE AS THAT WAS ALL THAT WAS AVAILABLE AT THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Oxygen Saturation; Respiratory Insufficiency

  MAUDE report 24696695 ↗