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Halyard 35162Recalls & reported problems

Avanos Medical, Inc. · ENDOTRACHEAL TUBE PEDIATRIC ORAL CURVED 3.5MM · 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 10680651351620), received between Jan 7, 2022 and Jan 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

  • Material Split, Cut or Torn1

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.

  • MalfunctionJan 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT A 1MM SIZE HOLE WAS FOUND ON THE INFLATING TUBE AND THE TUBE'S CONNECTING PART. THE USER STATED THAT THE CUFF WAS CHECKED BEFORE USE AND AFTER INSERTING THE TUBE INTO THE PATIENT AIR LEAKAGE COULD BE HEARD, THE TUBE WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13197356 ↗

Other Tube, Tracheal (W/Wo Connector) devices

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Sources and updates

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