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HUDSON RCI IPN913680Recalls & reported problems

Teleflex Incorporated · NEONATAL ISO-GARD DRAIN BREATHING CIRCUIT

All models of HUDSON RCI (152)

Data updated Oct 18, 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 14026704658852), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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 18, 2026.

Most reported problems

Device problems

  • Melted1

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.

  • MalfunctionApr 28, 2021Melted; Melted

    IT WAS REPORTED "THE CIRCUIT APPEARED TO START TO MELT, THERE IS NO REPORTED LEAK IN THE CIRCUIT. BUT THE EXPIRATORY LIMB IS DISCOLORED. THE PATIENT IS PRONE 18 HOURS A DAY WITH MEDIATION GOING THROUGH THE CIRCUIT. MUCOMYST AND PULMOZYME VIA AEROGEN AND ON NITRIC". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11740868 ↗

Sources and updates

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