Fisher & Paykel Healthcare RT280Recalls & reported problems
Fisher & Paykel Healthcare Limited · Dual limb adult circuit kit with Evaqua 2 technology · 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 09420012430373), received between Jul 15, 2020 and Apr 2, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Material Split, Cut or Torn2
- Degraded1
- Gas/Air Leak1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2025Gas/Air Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE REPRESENTATIVE, THAT TWO RT280 ADULT EVAQUA2 DUAL HEATED BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21759098 ↗MalfunctionJan 31, 2024Degraded; Degraded
A HEALTHCARE FACILITY REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE REPRESENTATIVE, THAT A RT280 ADULT EVAQUA2 DUAL HEATED BREATHING CIRCUIT WAS FOUND DAMAGED DURING PATIENT USE. THE DAMAGE WAS IDENTIFIED AFTER APPROXIMATELY 10 MINUTES OF PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18620111 ↗MalfunctionMar 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN NEW YORK REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT TWO RT280 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS WERE FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16595143 ↗MalfunctionApr 7, 2022Leak/Splash; Leak/Splash; Therapeutic or Diagnostic Output Failure
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT FOUR RT280 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14036701 ↗MalfunctionJul 15, 2020Leak/Splash; Material Split, Cut or Torn; Leak/Splash
A HEALTHCARE FACILITY IN OHIO REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT TWO RT280 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WERE FOUND WITH A SLIT CAUSING THE VENTILATORS TO ALARM. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10281051 ↗
Other Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer devices
- VOCSN V*Home, EnglishVentec Life Systems, Inc. · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer4 deaths318 reports
- F&P Evaqua 2 RT380Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer305 reports
- F&P Evaqua 2 RT265Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer114 reports
- F&P Evaqua 2 RT266Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer93 reports
- AirLife™ AH165Airlife · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall1 report
- AirLife™ AH165Airlife · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1 recall0 reports
- 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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