TRACOE twist REF 306-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04035324036219), received between Nov 28, 2024 and Mar 4, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Material Separation; Detachment of Device or Device Component

  ON 2026-02-06 IT WAS REPORTED THAT THE 15MM CONNECTOR CAME OFF WITH THE CATHETER MOUNT ON VENTILATOR DEPENDENT PATIENT. THE INNER CANNULA GOT STUCK IN THE TRACHEOSTOMY TUBE AND COULD NOT BE EASILY REMOVED WITHOUT THE CONNECTOR. EMERGENCY TRACHEOSTOMY CHANGE WAS PERFORMED. NO HEALTH EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511287 ↗
• MalfunctionJan 27, 2026Gas/Air Leak

  ON 2026-01-09 AN INCREASED RISK OF ASPIRATION DUE TO A FAULTY TRACHEOSTOMY TUBE CUFF WAS REPORTED. THE FAULTY TUBE HAD BEEN INSERTED ON (B)(6) 2025 AND WAS FOUND TO BE FAULTY ON (B)(6) 2026. PRIOR TO INSERTION, THE CUFF WAS TESTED, WITH NO AIR LEAKAGE NOTED AT THAT TIME. ON (B)(6) 2026, STAFF FOUND CUFF TO BE DEFLATED. THE PATIENT EXHIBITS INVOLUNTARY MOVEMENTS, INCLUDING LIFTING BOTH HANDS TOWARD THE CHEST AND FLEXING THE NECK DOWNWARDS, WHICH OCCUR DAILY AND MAY HAVE EXERTED PRESSURE ON THE TRACHEOSTOMY SYSTEM. THE TRACHEOSTOMY TUBE WAS REMOVED AND REPLACED BY NURSING STAFF. NO HEALTH EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187096 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 22-10-2025 IT WAS REPORTED THAT DURING MORNING ROUTINE CARE STAFF NOTICED THAT THE PORT WAS SLIGHTLY SPLIT. THE SUB-GLOTTIC PORT SPLIT COMPLETELY WHILE ASPIRATING. REMEDIAL ACTIONS WERE TAKEN BY HEALTHCARE FACILITY, PATIENT, OR USER SUBSEQUENT TO THE INCIDENT. THE PATIENT OF UNKNOWN AGE AND SEX REQUIRED UNPLANNED TRACHEOTOMY TUBE CHANGE. NO HEALTH EFFECT OF THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449453 ↗
• MalfunctionJun 30, 2025Decrease in Suction; Dent in Material; Defective Device; Lack of Effect; Decrease in Suction; Dent in Material; Defective Device; Lack of Effect

  1) WHAT WENT WRONG? WITHIN THE TIME FRAME OF (B)(6) 2025 TO (B)(6) 2025 IT WAS DETECTED BY THEMEDICAL STAFF THAT THE SUBGLOTTIC PORT HAS A KINK WHICH PREVENTS TO ASPIRE SECRETION.2) DESCRIPTION OF THE HEALTH EFFECTS: NO HEALTH EFFECT DESCRIBED. IT SEEMS THAT SUCTIONING SECRETION WAS NOT OR HARDLY POSSIBLE.

  Patient problems: Insufficient Information

  MAUDE report 22355912 ↗
• MalfunctionNov 28, 2024Mechanical Problem; Mechanical Problem

  AFTER 5 DAYS OF USE THE PORT OF THE SUCTION LINE OF THE TRACOE TWIST TRACHEOSTOMY CANNULA SPLIT. UNABLE TO OBTAIN ASPIRATES SO UNPLANNED ELECTIVE CHANGE PERFORMED. NO PERCEIVED HARM TO PATIENT AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804039 ↗