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HUDSON RCI IPN049845Recalls & reported problems

Teleflex Incorporated · AQUATHERM III,ELECTRONIC HEATER · Class 2

All models of HUDSON RCI (152)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704660794), received between Feb 2, 2021 and Jul 8, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (2 reports).

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

  • Insufficient Heating2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 8, 2021Insufficient Heating; Insufficient Heating

    IT WAS REPORTED "THE UNIT IS NOT HEATING UP". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12135145 ↗
  • MalfunctionFeb 2, 2021Insufficient Heating; Insufficient Heating

    IT WAS REPORTED ""AQUATHERM UNABLE TO PERFORM HEAT FUNCTION". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11267896 ↗

Other HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER devices

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Sources and updates

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