Fisher & Paykel Healthcare RT329Recalls & reported problems
Fisher & Paykel Healthcare Limited · Infant continuous flow circuit (0.3 to 10 L/min) singleheated with MR290 autofeed chamber and pressure relief valve · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09420012431073), received between Sep 23, 2024 and Oct 20, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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.
Reports received per month
Most reported problems
Device problems
- Disconnection1
- Fluid/Blood Leak1
- Gas/Air Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Low Oxygen Saturation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2025Gas/Air Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN RT329 INFANT CONTINUOUS FLOW CIRCUIT INFANT CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23344404 ↗MalfunctionJul 30, 2025Leak/Splash; Leak/Splash
A HEALTHCARE FACILITY IN FINLAND REPORTED THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS A PART OF AN RT329 INFANT CONTINUOUS FLOW CIRCUIT, HAD A HOLE ON THE SIDE OF THE CHAMBER AND WAS LEAKING WATER. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22672589 ↗InjuryNov 28, 2024Disconnection; Disconnection
FISHER & PAYKEL (F&P) HEALTHCARE WAS NOTIFIED VIA AN FDA MEDWATCH FORM THAT A HEALTHCARE FACILITY IN NORTH CAROLINA REPORTED THAT THE 'BLUE CAP' OF AN RT329 INFANT CONTINUOUS FLOW CIRCUIT DISLODGED CAUSING A LEAK. THE HEALTHCARE FACILITY REPORTED THAT AS A RESULT, THE PATIENT DESATURATED, AND MEDICAL INTERVENTION WAS REQUIRED. F&P HEALTHCARE HAVE REQUESTED FURTHER INFORMATION ABOUT THE REPORTED EVENT, INCLUDING INFORMATION ABOUT THE PATIENT CONDITION, SEQUENCE OF EVENTS, AND THE REPORTED FAULT WITH THE SUBJECT RT329 INFANT CONTINUOUS FLOW CIRCUIT. HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. F&P HEALTHCARE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
Patient problems: Low Oxygen Saturation
MAUDE report 20808360 ↗MalfunctionSep 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS A PART OF AN RT329 INFANT CONTINUOUS FLOW CIRCUIT SINGLE HEATED WITH PRESSURE RELIEF VALVE WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20288354 ↗
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- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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