TRACOE twist plusRecalls & reported problems across all models
Tracoe medical GmbH · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 13 models of TRACOE twist plus by Tracoe medical GmbH in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2024 and Jul 16, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TRACOE twist plus problems
Device problems
- Loss of or Failure to Bond24
- Gas/Air Leak7
- Detachment of Device or Device Component5
- No Apparent Adverse Event5
- Device Stenosis3
- Separation Failure3
- Mechanical Problem2
- Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Low Oxygen Saturation3
- Aspiration/Inhalation2
- Upper Respiratory Tract Irritation2
- Airway Obstruction1
- Cough1
- Distress1
- Hemorrhage/Blood Loss/Bleeding1
TRACOE twist plus models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRACOE twist plus REF 316-07Tube tracheostomy and tube cuff21 reports
- TRACOE twist plus REF 316-08Tube tracheostomy and tube cuff16 reports
- TRACOE twist plus REF 311-07Tube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 311-08Tube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 312-07Tube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 521-07Tube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 521-08Tube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 521-09Tube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 521-09-XTube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 888-316-07Tube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 316-09Tube tracheostomy and tube cuff1 report
- TRACOE twist plus REF 316-10Tube tracheostomy and tube cuff1 report
- TRACOE® twist plus REF 316-08-PTube tracheostomy and tube cuff1 report
Recent TRACOE twist plus adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJul 7, 2026Loss of or Failure to Bond
SUBGLOTTIC PORT FOUND DISCONNECTED IN BED. PATIENT EXPERIENCED DIFFICULTY DURING RESPIRATORY WEAR. BEDSIDE NURSE NOTED SUBGLOTTIC PORT NOT ATTACHED TO TRACHEOSTOMY UNABLE TO LOCATE SUBGLOTTIC PORT. QUERY FALLEN OR BEEN PULLED OFF. NO HARM TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25729876 ↗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 27, 2026Device Stenosis
WHEN THE HCP DID A REGULAR CHANGE OF THE INNER CANULA, DUE TO A CLEANING ROUTINE, HE GRABBED A NEW INNER CANULA. HE INSERTED IT INTO THE PATIENT. AFTER A WHILE THE PATIENT STARTED COUGHING AND HAD A BIT OF SPUTUM. WHEN THE HCP WANTED TO INSERT A SUCTION TUBE INTO THE CANULA, HE WAS NOT ABLE TO REACH THE SPUTUM DUE TO A PIECE OF PLASTIC INSIDE THE INNER CANULA.
Patient problems: Airway Obstruction
MAUDE report 25300208 ↗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 ↗MalfunctionMay 5, 2026Use of Device Problem; Device Stenosis
IT WAS REPORTED ON (B)(6) 2026 THE PATIENT EXPERIENCED A DROP IN OXYGEN SATURATION AND COULD NOT BE SUCTIONED ENDOTRACHEALLY. THE LOWER PART OF THE CANNULA HAD TORN, AND THE ENDS HAD CURLED INWARD. THIS BLOCKED THE SUCTION PATH. A BRONCHOSCOPY WAS PERFORMED, THE CANNULA WAS REPLACED, AND VENTILATION RESUMED WITHOUT ISSUES.
Patient problems: Respiratory Failure
MAUDE report 25079696 ↗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 21, 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 24934657 ↗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 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 ↗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
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 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 24660877 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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