TRACOE twist plus REF 316-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04035324019076), received between Oct 11, 2024 and Jul 16, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25835582 ↗
• MalfunctionApr 17, 2026Loss of or Failure to Bond

  SUB-GLOTTIC PORT BECAME DETACHED FROM THE BODY OF THE TUBE. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908043 ↗
• MalfunctionMar 23, 2026Loss of or Failure to Bond

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660964 ↗
• MalfunctionMar 13, 2026Loss of or Failure to Bond

  IT WAS REPORTED ON (B)(6) 2026 THAT THE SUBGLOTTIC PORT OF THE TRACHEOSTOMY HAD BECOME DETACHED. THE PATIENT WAS IMMEDIATELY REVIEWED AND A SAFETY ASSESSMENT OF THE TRACHEOSTOMY TUBE WAS UNDERTAKEN. IT WAS CONFIRMED THAT THE SUBGLOTTIC PORT HAD BECOME DETACHED. THE TRACHEOSTOMY CUFF PRESSURE WAS CHECKED AND THE PATIENT'S OXYGEN SATURATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597347 ↗
• MalfunctionMar 13, 2026Loss of or Failure to Bond

  PATIENT IN HIS ROOM AND STAFF OBSERVED THE SUBGLOTTIC PORT WAS DETACHED. TRACHEOSTOMY CHANGED DONE. USED FOR 25 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597267 ↗
• MalfunctionMar 10, 2026Loss of or Failure to Bond

  IT WAS REPORTED ON (B)(6) 2026 THAT SUBGLOTTIC PORT DETACHED FROM TRACHEOSTOMY. PATIENT WAS DISTRESSED. CLINICAL SPECIALIST HAS MANAGED TO REATTACH THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558379 ↗
• MalfunctionMar 2, 2026Loss of or Failure to Bond

  ON (B)(6) 2026, SUBGLOTTIC DETACHMENT 17 DAYS POST INSERTION OF TRACHEOSTOMY WAS REPORTED. PATIENT REQUIRED TRACHEOSTOMY CHANGE. NO HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482068 ↗
• MalfunctionFeb 11, 2026Loss of or Failure to Bond

  SUBGLOTTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT. THE PATIENT REQUIRED AN TRACHEOSTOMY CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311638 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SUBGLOTTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT. NURSES FOUND THAT THE SUBGLOTTIC SUCTION PORT WAS NOT ATTACHED TO THE TRACHEOSTOMY TUBE DURING NORMAL USE. 2) DESCRIPTION OF THE HEALTH EFFECTS: NO ADVERSE HEALTH EFFECTS WERE REPORTED. PATIENT IS UNDER CONTINUED MONITORING, AND THE TRACHEOSTOMY TUBE WILL BE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450500 ↗
• MalfunctionAug 13, 2025Mechanical Problem; Mechanical Problem

  SUBGLOTTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791763 ↗
• MalfunctionJun 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SUBGLOTTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT.

  Patient problems: Hypoventilation

  MAUDE report 22317601 ↗
• 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: Distress

  MAUDE report 22217741 ↗
• MalfunctionMay 28, 2025Separation Failure; No Apparent Adverse Event; Separation Failure; No Apparent Adverse Event

  SUBGLOTTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094874 ↗
• MalfunctionApr 30, 2025Separation Failure; No Apparent Adverse Event; Separation Failure; No Apparent Adverse Event

  SUBGLOTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933897 ↗
• MalfunctionApr 25, 2025Separation Failure; No Apparent Adverse Event; Separation Failure; No Apparent Adverse Event

  SUBGLOTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907318 ↗
• MalfunctionMar 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  SUBGLOTIC SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA DURING TREATMENT.

  Patient problems: Cough; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631563 ↗
• MalfunctionJan 3, 2025Gas/Air Leak; Gas/Air Leak

  1) CUFF LEAK WAS OBSERVED DURING USE AFTER ROUND ABOUT 1 MONTH OF USE, WHICH IS APPROXIMATELY THE MAXIMUM DURATION OF USE OF 29 DAYS. IT IS REPORTED THAT A PRIORI CUFF TESTING WAS DONE AND PASSED. 2) 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 21066112 ↗
• MalfunctionDec 2, 2024Mechanical Problem; Mechanical Problem

  AFTER 1 DAYS OF USE THE PORT OF THE SUCTION LINE OF THE TRACOE TWIST PLUS TRACHEOSTOMY CANNULA SPLIT. DIFFICULT TO OBTAIN ASPIRATES SO PLANNED ELECTIVE CHANGE PERFORMED THE NEXT DAY. NO PERCEIVED HARM TO PATIENT AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818748 ↗
• MalfunctionOct 30, 2024Gas/Air Leak; Gas/Air Leak

  1) CUFF LEAK WAS OBSERVED DURING USE AFTER SOME TIME OF USE. IT IS NOT REPORTED IF A PRIORI CUFF TESTING WAS DONE. 2) NO HEALTH EFFECT TO THE PATIENT OCCURED. THE TRACHEOSTOMY TUBE WITH THE CUFF PROBLEM WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565167 ↗
• MalfunctionOct 29, 2024Gas/Air Leak; Gas/Air Leak

  1) VERY SLOW CUFF LEAK WAS OBSERVED DURING USE AFER SOME TIME OF USE. NO LEAK DETECTED BY THE A PRIORI CUFF TESTING. COUGHING OF PATIENT GIVES A HINT OF A LESS SEALING CUFF. 2) NO HEALTH EFFECT TO THE PATIENT OCCURED. THE TRACHEOSTOMY TUBE WITH THE CUFF PROBLEM WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556289 ↗
• MalfunctionOct 11, 2024No Apparent Adverse Event; No Apparent Adverse Event

  SUCTION LINE DETACHED FROM TRACHEOSTOMY CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425519 ↗