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AVANOS B30611Recalls & reported problems

Avanos Medical, Inc. · Closed Suction System for Neonates / Pediatrics · Class 1

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 00609038000398), received between Feb 9, 2023 and Feb 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Crack1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionFeb 9, 2023Crack; Crack

    IT WAS REPORTED "THE RT [RESPIRATORY THERAPIST] NOTICED THE SALINE LEAKING FROM THE MANIFOLD. THE CRACK IS IN THE SAME SPOT AS WAS REPORTED ON EARLIER INCIDENTS...PRESSURE WAS 26 PIP (PEAK INSPIRATORY PRESSURE) WAS 13 RATE OF 30 100% OXYGEN. THE [PATIENT] WAS ON A RADIANT HEATER." THERE WAS NO REPORTED INJURY.

    Patient problems: Insufficient Information

    MAUDE report 16334940 ↗

Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices

All CATHETERS, SUCTION, TRACHEOBRONCHIAL devices →

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