F&P Evaqua 2 RT266Recalls & reported problems
Fisher & Paykel Healthcare Limited · Infant ventilator circuit (0.3 to 4 L/min) dual heated with MR290 autofeed chamber · Class 2
All models of F&P Evaqua 2 (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Fisher & Paykel Evaqua 2 RT266 is an infant dual-heated ventilator breathing circuit. Its 91 adverse event reports mostly describe leaks, cracks, and failed pre-use leak or self-tests, often found before patient use, with no deaths and no injuries. There are no recalls for this device. Reports mentioning it fell from 18 to 6 in the past 12 months compared with the previous 12 months.
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
- 93
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 09420012431103), received between Mar 8, 2017 and Sep 24, 2026 — classified as 93 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (46 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak46
- Leak/Splash39
- Therapeutic or Diagnostic Output Failure14
- Crack8
- Failure of Device to Self-Test8
- Connection Problem4
- Fluid/Blood Leak3
- Material Puncture/Hole3
Patient problems
- No Clinical Signs, Symptoms or Conditions89
- No Patient Involvement3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Crack; Gas/Air Leak
A distributor reported on behalf of a healthcare facility in Japan, via a Fisher & Paykel (F&P) Healthcare field representative, that an RT266 Infant Dual-Heated Evaqua2 Breathing Circuit failed the pre-use ventilator leak test due to a crack on the dome of the MR290V Vented Autofeed Humidification Chamber provided with the breathing circuit kit. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877282 ↗MalfunctionSep 4, 2026Overfill
A healthcare facility in Finland reported via a Fisher & Paykel (F&P) Healthcare field representative that an MR290V Vented Autofeed Humidification Chamber provided with an RT266 Infant Dual-Heated Evaqua2 Breathing Circuit was found to be overfilling with water within 5 minutes of commencing patient use.There was no reported patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50601785 ↗MalfunctionJun 1, 2026Fluid/Blood Leak; Material Puncture/Hole
A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE RT266 DUAL HEATED INFANT CIRCUIT KIT WITH EVAQUA 2 TECHNOLOGY, HAD A HOLE IN THE BOTTOM OF THE CHAMBER, CAUSING WATER TO LEAK. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355786 ↗MalfunctionMar 4, 2026Gas/Air Leak
A HEALTHCARE FACILITY IN FINLAND REPORTED THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510362 ↗MalfunctionFeb 25, 2026Material Puncture/Hole
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT THE INSPIRATORY TUBING OF AN RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND WITH A CRACK PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24449612 ↗MalfunctionDec 4, 2025Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem
A HEALTHCARE FACILITY IN JAPAN REPORTED ON BEHALF OF ANOTHER HEALTHCARE FACILITY VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23721540 ↗MalfunctionNov 20, 2025Crack; Gas/Air Leak; Crack; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN COLORADO, THAT THE TUBING OF AN RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING DURING PATIENT USE. FOLLOWING INSPECTION BY THE HEALTHCARE FACILITY, DAMAGE WAS IDENTIFIED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610580 ↗MalfunctionNov 6, 2025Gas/Air Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN JAPAN REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493617 ↗MalfunctionOct 15, 2025Gas/Air Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN CHINA REPORTED THAT A RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23286770 ↗MalfunctionSep 2, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22948715 ↗MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS LEAKING WATER. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22869943 ↗MalfunctionJun 5, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22155752 ↗MalfunctionMay 5, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21965161 ↗MalfunctionApr 9, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING FROM THE Y-PIECE PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21809628 ↗MalfunctionApr 7, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21793835 ↗MalfunctionMar 24, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THE HEALTHCARE FACILITY IDENTIFIED A LEAK FROM THE EXPIRATORY TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21674660 ↗MalfunctionMar 11, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21569618 ↗MalfunctionFeb 4, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309510 ↗MalfunctionFeb 4, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309345 ↗MalfunctionJan 30, 2025Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT266 INFANT DUAL-HEATED EVAQUA2 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 21280320 ↗MalfunctionJan 21, 2025Connection Problem; Device Dislodged or Dislocated; Connection Problem; Device Dislodged or Dislocated
A HEALTHCARE FACILITY IN VIRGINIA REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT TEMPERATURE PROBES WERE DISLODGING FROM RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS. THE HEALTHCARE FACILITY HAS NOT CONFIRMED THE NUMBER OF EVENTS, THE QUANTITY OF UNITS AFFECTED, OR IF THERE WAS ANY PATIENT INVOLVEMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21204397 ↗MalfunctionJan 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21154849 ↗MalfunctionDec 15, 2024Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN RT266 INFANT VENTILATOR CIRCUIT DUAL HEATED WITH MR290 AUTOFEED CHAMBER FAILED THE VENTILATOR LEAK TEST DURING SETUP AND PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20935770 ↗MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20803079 ↗MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20803057 ↗
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- HUDSON RCI IPN046880Teleflex Incorporated · 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
- AirLife™ AH165Airlife · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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