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Halyard 35165Recalls & reported problems

Avanos Medical, Inc. · ENDOTRACHEAL TUBE PEDIATRIC ORAL CURVED 5.MM · Class 2

All models of Halyard (232)

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 10680651351651), received between Nov 6, 2020 and Nov 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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

  • Inflation Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 6, 2020Inflation Problem; Inflation Problem

    IT WAS REPORTED THAT THE "CUFF DID NOT INFLATE. THE TUBE WAS REPLACED FOR NEW ONE. NO PATIENT INJURY." ADDITIONAL INFORMATION RECEIVED 29-OCT-2020 INDICATED, "RIGHT AFTER INTUBATION, PRESSURE OF THE CUFF WAS DECREASED AND THE LISTED DEVICE WAS EXCHANGED FOR A NEW ONE." "NO VISIBLE DAMAGE HAS BEEN REPORTED ONLY DECREASED PRESSURE WAS OBSERVED BUT IT MIGHT BE DAMAGE ON THE CUFF. WE ALSO DOUBLE-CHECKED THAT NO PATIENT INJURY OCCURRED FOR THIS CASE."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10804839 ↗

Other Tube, Tracheal (W/Wo Connector) devices

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Sources and updates

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