Fisher & Paykel Healthcare RT225Recalls & reported problems
Fisher & Paykel Healthcare Limited · Infant Ventilator (>4 L/min) Single Heated with MR290 Autofeed Chamber · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Fisher & Paykel RT225 is an infant ventilator circuit with a heated breathing tube and an autofeed chamber. Reports mostly describe water or air leaking from the chamber or circuit, cracked or split chamber parts, and circuits that failed a leak test during setup. There are 31 reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 09420012431080), received between Oct 25, 2017 and Feb 15, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (13 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash13
- Crack11
- Material Split, Cut or Torn6
- Gas/Air Leak5
- Fluid/Blood Leak3
- Disconnection2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient2
- Low Oxygen Saturation1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2026Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT225 INFANT SINGLE-HEATED VENTILATOR CIRCUIT (>4 L/MIN) FAILED THE VENTILATOR LEAK TEST DURING SET UP AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341693 ↗MalfunctionFeb 2, 2026Crack; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT225 INFANT BREATHING CIRCUIT WAS FOUND LEAKING WATER FROM A CRACK DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24242874 ↗MalfunctionJan 19, 2026Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT TWO MR290V AUTOFEED HUMIDIFICATION CHAMBERS, PROVIDED AS A PART OF AN RT225 INFANT VENTILATOR CIRCUIT SINGLE HEATED WITH MR290 AUTOFEED CHAMBER, WERE FOUND CRACKED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24110484 ↗MalfunctionJan 19, 2026Crack; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT225 INFANT VENTILATOR CIRCUIT SINGLE HEATED WITH MR290 AUTOFEED CHAMBER, WAS FOUND CRACKED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24110470 ↗MalfunctionMay 30, 2025Mechanical Problem; Mechanical Problem
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE WATER TRAP OF A RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22112106 ↗MalfunctionApr 22, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A RT225 INFANT BIAS FLOW BREATHING CIRCUIT FAILED A VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21886331 ↗MalfunctionFeb 4, 2025Crack; Leak/Splash; Crack; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT225 INFANT BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309457 ↗MalfunctionDec 22, 2024Crack; Leak/Splash; Crack; Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT225 INFANT BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING SET UP AND PRIOR TO PATIENT USE. UPON RECEIPT AT THE FISHER & PAYKEL (F&P) HEALTHCARE REGIONAL SERVICE CENTRE, A CRACK ON THE DOME OF THE CHAMBER WAS IDENTIFIED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20997750 ↗MalfunctionSep 25, 2024Gas/Air Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN RT225 INFANT VENTILATOR CIRCUIT FAILED A VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20298091 ↗MalfunctionAug 30, 2024Disconnection; Mechanical Problem; Disconnection; Mechanical Problem
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN RT225 INFANT VENTILATOR CIRCUIT SINGLE HEATED WITH MR290 AUTOFEED CHAMBER DISCONNECTED DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20104385 ↗MalfunctionJun 21, 2024Crack; Leak/Splash; Crack; Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT225 INFANT VENTILATOR CIRCUIT WAS FOUND LEAKING WATER FROM A CRACK ON THE CHAMBER'S DOME AFTER TWO DAYS OF USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT'S OXYGEN SLIGHTLY DECREASED TO AROUND 85%, HOWEVER NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Low Oxygen Saturation
MAUDE report 19581904 ↗MalfunctionJun 12, 2024Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND LEAKING WATER BETWEEN THE CHAMBER'S DOME AND BASE DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525395 ↗MalfunctionFeb 22, 2024Leak/Splash; Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED THAT A RT225 INFANT BIAS FLOW BREATHING CIRCUIT FAILED A VENTILATOR LEAK TEST BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18764579 ↗MalfunctionDec 20, 2023Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH A RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND CRACKED AND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18366788 ↗MalfunctionOct 26, 2023Leak/Splash; Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH A RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND LEAKING DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18016984 ↗MalfunctionJul 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF A RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND BROKEN BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339746 ↗MalfunctionJul 17, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT A RT225 INFANT BIAS FLOW BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339744 ↗MalfunctionJun 27, 2023Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND LEAKING AIR DURING VENTILATOR LEAK TEST BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17214076 ↗MalfunctionMay 30, 2023Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A RT225 INFANT BIAS FLOW BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017699 ↗MalfunctionMay 23, 2023Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A RT225 INFANT BIAS FLOW BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16989981 ↗MalfunctionApr 28, 2023Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A RT225 INFANT BIAS FLOW BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16829960 ↗MalfunctionApr 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16679183 ↗MalfunctionAug 8, 2022Crack; Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE INSPIRATORY LIMB OF AN RT225 INFANT VENTILATOR CIRCUIT WAS FOUND CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189369 ↗MalfunctionMay 9, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT A RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS LEAKING DURING USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14341818 ↗MalfunctionApr 8, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE TUBING IN A RT225 INFANT BIAS FLOW BREATHING CIRCUIT HAD A HOLE. THERE WAS NO PATIENT INVOLVMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14049215 ↗
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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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