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Shiley 4CN65ARecalls & 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
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521172456), received between Jan 29, 2020 and Jun 28, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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

  • Disconnection1
  • Gas/Air Leak1
  • Use of Device Problem1

Patient problems

  • No Consequences Or Impact To Patient1
  • Pulmonary Emphysema1
  • Unintended Extubation1

Recent adverse event reports

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

  • MalfunctionJun 28, 2022Gas/Air Leak; Gas/Air Leak

    ACCORDING TO THE REPORTER, THE CUFF WAS TESTED AND INFLATED PRIOR TO USE. INTRA-OPERATIVELY, THE CUFF WAS INFLATED WITH AIR AND THE CLINICIANS NOTICED A CUFF LEAK. THE TUBE WAS WITHDRAWN TO BE REPLACED BY A NEW ONE. WHEN REMOVED, CLINICIANS NOTICED TINY BUBBLES AND MICRO DROPLETS IN THE CUFF. THERE WAS NO CUT, TEAR OR HOLE OBSERVED.

    Patient problems: Unintended Extubation

    MAUDE report 14843915 ↗
  • InjuryJun 2, 2021Disconnection; Disconnection

    ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE TRACHEOSTOMY TUBE KEPT POPPING OUT. THE EVENT RESULTED FOR THE PATIENT TO EXPERIENCE BAROTRAUMA AND SURGICAL EMPHYSEMA. THE DEVICE WAS EXPLANTED.

    Patient problems: Pulmonary Emphysema

    MAUDE report 11920091 ↗
  • MalfunctionJan 29, 2020Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, THE DEVICE SUB CANNULA WAS NOT LOCKED, DID NOT CLICK WHEN THE PATIENT COUGHS AND IT WAS EXPELLED. IT WAS INDICATED THAT THERE WERE BLEEDING AND DIFFICULTY IN CLEANING OF TRACHEOSTOMIZED PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9641899 ↗

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.