Skip to content

TRACOE silcosoft REF 373-4.0-C48Recalls & reported problems

Tracoe medical GmbH · Tracheostomy Tube for Children · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324031405), received between Apr 16, 2021 and Apr 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

    UPON ASSESSMENT OF TRACHEOSTOMY CUFF, IT WAS NOTED THAT THE CUFF WAS DEFLATED ALTHOUGH IT WAS INFLATED WITH 2 MLS OF STERILE WATER A FEW HOURS PRIOR. THE DECISION WAS MADE TO CHANGE THE TRACHEOSTOMY TUBE. ON EXAMINATION AFTER, IT WAS NOTED THAT THE CUFF WAS BLOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11676901 ↗

Other Tube Tracheostomy And Tube Cuff devices

All Tube Tracheostomy And Tube Cuff devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page