TRACOE twist plus REF 316-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04035324019083), received between Jun 4, 2025 and Jul 7, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Loss of or Failure to Bond

  IT WAS REPORTED SUBGLOTTIC PORT WAS DETACHED. THE ARTICLE NUMBER AND THE LOT NUMBER WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25729453 ↗
• MalfunctionMay 19, 2026Loss of or Failure to Bond

  IT WAS REPORTED SUBGLOTTIC PORT DETACHED, SUBGLOTTIC LOAD ASPIRATION.

  Patient problems: Upper Respiratory Tract Irritation

  MAUDE report 25212395 ↗
• MalfunctionApr 23, 2026Loss of or Failure to Bond

  SUBGLOTTIC SUCTION LINE DETACHED SUBGLOTTIC LOAD ASPIRATION TUBE EXCHANGED.

  Patient problems: Upper Respiratory Tract Irritation

  MAUDE report 24964837 ↗
• MalfunctionApr 17, 2026Loss of or Failure to Bond

  SUBGLOTTIC PORT FELL OFF. TUBE CHANGED. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910041 ↗
• MalfunctionApr 17, 2026Loss of or Failure to Bond

  SUBGLOTTIC PORT FOUND DISCONNECTED IN BED. TUBE CHANGED. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908705 ↗
• MalfunctionApr 10, 2026Loss of or Failure to Bond

  THE SUBGLOTTIC PORT OF THE TRACHEOSTOMY BECAME DETACHED FROM THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843090 ↗
• MalfunctionApr 10, 2026Loss of or Failure to Bond

  SUBGLOTTIC PORT FOUND DISCONNECTED. TUBE CHANGED ON (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838616 ↗
• MalfunctionMar 23, 2026Loss of or Failure to Bond

  SUBGLOTTIC PORT BECAME DETACHED FROM TRACHEOSTOMY TUBE; THE PATIENT IS VERY DEPENDENT ON SGP SUCTION AND VENTILATED OVERNIGHT. THIS REQUIRED A TRACHEOSTOMY CHANGE, THIS CAUSED SIGNIFICANT UPSET TO PATIENT WHO WAS VERY DISTRESS AND UPSET USED FOR 19 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660286 ↗
• MalfunctionMar 12, 2026Loss of or Failure to Bond

  SUB-GLOTTIC PORT BECAME DETACHED FROM THE BODY OF THE TUBE WHEN PT WAS BEING ROLLED. NO PRESSURE OR PULLING OF TUBE. THIS REQUIRED AN EMERGENCY TUBE CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577469 ↗
• MalfunctionMar 11, 2026Loss of or Failure to Bond

  IT WAS REPORTED ON 2026-02-23 THAT SUBGLOTTIC SUCTION PORT DETACHED FROM THE TUBE. THE PATIENT REQUIRED URGENT TRACHEOSTOMY CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568372 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  ON (B)(6) 2026 PILOT BALLOON DETACHMENT ON THE TRACHEOSTOMY WAS REPORTED. EMERGENCY TUBE CHANGE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518711 ↗
• MalfunctionMar 5, 2026Loss of or Failure to Bond

  ON (B)(6) 2026 SUBGLOTTIC SUCTION PORT DETACHMENT WAS REPORTED. PATIENT REQUIRED EMERGENCY TUBE CHANGE. NO HEALTH EFFECT REPORTED.

  Patient problems: Aspiration/Inhalation; Low Oxygen Saturation

  MAUDE report 24518441 ↗
• MalfunctionMar 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED ON 2026-02-11 THAT SUBGLOTTIC PORT BECAME DETACHED FROM TRACHEOSTOMY TUBE. THE PATIENT IS VERY DEPENDANT ON SGP SUCTION AND VENTILATED OVERNIGHT, REQUIRED AN EMERGENCY TRACHEOSTOMY CHANGE. THE PATIENT TOOK A LONG TIME TO OPTIMISE POST CUFF DEFLATION DUE TO BURDEN OF SECRETIONS, CAUSING DISCOMFORT AND DISTRESS AND DROP IN SATURATIONS.

  Patient problems: Aspiration/Inhalation; Low Oxygen Saturation

  MAUDE report 24517308 ↗
• MalfunctionFeb 6, 2026Loss of or Failure to Bond

  SUBGLOTTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT. THE PATIENT WAS DEPENDENT ON SGP SUCTION AND VENTILATED OVERNIGHT. THE PATIENT REQUIRED AN TRACHEOSTOMY CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275840 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SUBGLOTTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22222757 ↗
• MalfunctionJun 4, 2025Gas/Air Leak; Gas/Air Leak

  1) WHAT WENT WRONG: CUFF LEAK WAS OBSERVED DURING USE AFTER MORE THAN 1 MONTH OF USE, WHICH IS MORE THAN THE ALLOWED DURATION OF USE OF 29 DAYS. CUFF PRESSURE WAS TESTED WITH MANOMETER AND INFLATION WAS DONE WITH MONOMETER AND SYRINGE. THE PRESSURE DECREASES IMMEDIATELY. IT IS NOT REPORTED IF A PRIORI CUFF TESTING WAS DONE AND PASSED. 2) HEALTH EFFECT: NO HEALTH EFFECT TO THE PATIENT REPORTED. THE TRACHEOSTOMY TUBE WITH THE CUFF PROBLEM WAS CHANGED THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139949 ↗