TRACOE twist REF 302-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04035324033614), received between Oct 30, 2024 and Apr 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Gas/Air Leak; Failure to Deflate

  THE CANNULAS DON'T LAST A WEEK, (6-7 DAYS) THEY LEAK, THEY HAVE TO BE INFLATED SEVERAL TIMES, AND WHEN THEY WANT TO DEFLATE THEM COMPLETELY, THEY CAN'T SUCK OUT THE AIR, THEY TAKE THEM OUT WITH A PARTIALLY INFLATED CUFF. THEY NOTICED THAT THE BOTTOM OF THE CUFF TURNS IN TOWARDS THE BOTTOM OF THE CANNULA, MEANING THAT THE CUFF FIXATION OF THE PATIENT SIDE WAS PARTLY DETACHED. THEY REALIZED THIS BECAUSE THE SATURATION HAD DROPPED, AND AS A LAST RESORT THEY TRIED TO CHANGE THE CANNULA NO HEALTH EFFECT ON THE PATIENT REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24963024 ↗
• MalfunctionApr 23, 2026Gas/Air Leak; Failure to Deflate

  THE CANNULAS DON'T LAST A WEEK, (6-7 DAYS) THEY LEAK, THEY HAVE TO BE INFLATED SEVERAL TIMES, AND WHEN THEY WANT TO DEFLATE THEM COMPLETELY, THEY CAN'T SUCK OUT THE AIR, THEY TAKE THEM OUT WITH A PARTIALLY INFLATED CUFF. THEY NOTICED THAT THE BOTTOM OF THE CUFF TURNS IN TOWARDS THE BOTTOM OF THE CANNULA, MEANING THAT THE CUFF FIXATION OF THE PATIENT SIDE WAS PARTLY DETACHED. THEY REALIZED THIS BECAUSE THE SATURATION HAD DROPPED, AND AS A LAST RESORT THEY TRIED TO CHANGE THE CANNULA NO HEALTH EFFECT ON THE PATIENT REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24962197 ↗
• MalfunctionOct 30, 2024Gas/Air Leak; Gas/Air Leak

  1) CUFF RUPTURE AND LEAK WAS OBSERVED DURING USE AFTER 15 DAYS OF USE. IT IS NOT REPORTED IF A PRIORI CUFF TESTING WAS DONE. 2) TEMPORARY LOW SATURATION DETECTED. THE TRACHEOSTOMY TUBE WITH THE CUFF PROBLEM WAS CHANGED. NO LASTING HEALTH EFFECT TO THE PATIENT OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566090 ↗