Fisher & Paykel Healthcare RT226Recalls & reported problems
Fisher & Paykel Healthcare Limited · Infant Ventilator (0.3 to 4L/min) Single Heated with MR290 Autofeed Chamber · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09420012431165), received between Aug 28, 2017 and Feb 8, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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/Splash3
- Crack2
- Break1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 2024Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL (F&P) HEALTHCARE REPRESENTATIVE IN JAPAN THAT THE WATER TRAP OF A RT226 INFANT VENTILATOR BREATHING CIRCUIT WAS OBSERVED TO BE CRACKED WHEN BEING REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18673617 ↗MalfunctionMar 20, 2023Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A RT226 INFANT LOW FLOW BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16576334 ↗MalfunctionNov 26, 2020Break; Leak/Splash; Material Puncture/Hole; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A RT226 INFANT VENTILATOR BREATHING CIRCUIT HAD A HOLE IN THE AND FAILED THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10912710 ↗MalfunctionAug 22, 2018Leak/Splash; Leak/Splash
A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT226 INFANT LOW FLOW BREATHING CIRCUIT FAILED THE INITIAL LEAK TEST OF THE SERVO-I VENTILATOR. THEY ALSO NOTICED AN AIR LEAK FROM THE CONNECTION BETWEEN THE EXPIRATORY LIMB AND THE WATER TRAP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7804054 ↗MalfunctionAug 28, 2017Crack; Crack
A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE RT226 INFANT LOW FLOW BREATHING CIRCUIT HAD A CRACK ON THE SWIVEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6823320 ↗
Other Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer devices
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- F&P Evaqua 2 RT266Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer93 reports
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- HUDSON RCI IPN046879Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
- HUDSON RCI IPN046880Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
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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