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Shiley 9CN90HRecalls & reported problems

Covidien LP · Adult Flexible Tracheostomy Tube with TaperGuard Cuff 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
3
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521176352), received between Apr 18, 2022 and Jul 13, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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

  • Use of Device Problem2
  • Defective Component1
  • Gas/Air Leak1

Patient problems

  • Unintended Extubation3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 13, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

    ACCORDING TO THE REPORTER, THE CUFF WAS CHECKED AND TESTED USING A SLIP TIP SYRINGE ADDING 5 TO 7CC OF AIR AND FOUND NO ISSUE. THE DEVICE WAS PLACED ON A VENT. BUT, THE CUFF WAS FOUND TOO SMALL FOR THE TRACHEA DESPITE HAVING A DECISION BASED ON IBW AND NECK THICKNESS OF THE PATIENT. THE DEVICE HAD A LEAK AND THE TUBE OF THE PATIENT WAS REPLACED BY XLT.

    Patient problems: Unintended Extubation

    MAUDE report 15005894 ↗
  • MalfunctionApr 18, 2022Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE HAD INFLATION/DEFLATION ISSUE. THE PRESSURE WAS DOCUMENTED EVERY 12 HOURS AND FLUCTUATION REMAINED 10-20CMH20. RECANNULATION WAS DONE BUT ISSUE REMAINED.

    Patient problems: Unintended Extubation

    MAUDE report 14135930 ↗
  • MalfunctionApr 18, 2022Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE HAD INFLATION/DEFLATION ISSUE. THE PRESSURE WAS DOCUMENTED EVERY 12 HOURS AND FLUCTUATION REMAINED 10-20CMH20. RECANNULATION WAS DONE BUT ISSUE REMAINED.

    Patient problems: Unintended Extubation

    MAUDE report 14135917 ↗

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.