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Shiley 5UN70HRecalls & reported problems

Covidien LP · Adult Flexible Tracheostomy Tube Cuffless Disposable Inner Cannula · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521176246), received between Feb 25, 2020 and Mar 10, 2022 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Mar 24, 2023Open, Classified

    A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

    Z-1357-2023 · Root cause: Component change control · FDA record ↗

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Gas/Air Leak1

Patient problems

  • No Consequences Or Impact To Patient1
  • Unintended Extubation1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 10, 2022Gas/Air Leak; Gas/Air Leak

    ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF LEAKAGE. THE TUBE WAS REPLACED SUCCESSFULLY. ANOTHER CUFF LEAKAGE OCCURRED AND THE PATIENT HAD A REPLACEMENT OF THE TUBE FOR THE SECOND TIME.

    Patient problems: Unintended Extubation

    MAUDE report 13720679 ↗
  • MalfunctionFeb 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

    ACCORDING TO THE REPORTER, THE DEVICE HAD SECRETION LEAKAGE WHEN THE PATIENT COUGHED UP WITHOUT THE UNIVERSAL CONNECTOR. THERE WAS NO DECANNULATION/REINTUBATION REQUIRED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9749937 ↗

Other Tube tracheostomy and tube cuff devices

All Tube tracheostomy and tube cuff devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.