F&P Evaqua 2Recalls & reported problems across all models
Fisher & Paykel Healthcare Limited · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 522
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of F&P Evaqua 2 by Fisher & Paykel Healthcare Limited in the FDA's device registry (GUDID). Together they are named in 522 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2017 and Sep 24, 2026 — classified as 3 injuries, 519 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (204 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported F&P Evaqua 2 problems
Device problems
- Leak/Splash204
- Gas/Air Leak193
- Crack79
- Fluid/Blood Leak52
- Break34
- Therapeutic or Diagnostic Output Failure29
- Failure of Device to Self-Test19
- Material Split, Cut or Torn17
Patient problems
- No Clinical Signs, Symptoms or Conditions493
- No Patient Involvement19
- No Known Impact Or Consequence To Patient6
- Low Oxygen Saturation5
- Bradycardia1
- Hypoxia1
F&P Evaqua 2 models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- F&P Evaqua 2 RT380Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer305 reports
- F&P Evaqua 2 RT265Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer114 reports
- F&P Evaqua 2 RT266Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer93 reports
- F&P Evaqua 2 RT385Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer10 reports
Recent F&P Evaqua 2 adverse event reports
The 15 most recent reports across all models, 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 21, 2026Fluid/Blood Leak; Leak/Splash; Mechanical Problem
A distributor on behalf of a healthcare facility in China reported that an MR290V Autofeed Humidification Chamber, provided as a part of an RT265 Dual Heated Infant Circuit Kit, was found leaking water after one day of patient use. There was no reported patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835024 ↗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 ↗MalfunctionAug 3, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111191 ↗MalfunctionJun 8, 2026Material Puncture/Hole; Gas/Air Leak
A HEALTHCARE FACILITY IN CHINA REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE RT380 ADULT 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 25436643 ↗MalfunctionJun 4, 2026Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE RT265 DUAL HEATED INFANT CIRCUIT KIT WAS FOUND TO BE LEAKING BEFORE USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402626 ↗MalfunctionJun 4, 2026Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE RT265 DUAL HEATED INFANT CIRCUIT KIT WAS FOUND TO BE LEAKING DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402603 ↗MalfunctionJun 4, 2026Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAN AN MR290V AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS PART OF AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT, WAS FOUND TO BE LEAKING BEFORE USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399522 ↗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 ↗MalfunctionMay 24, 2026Loose or Intermittent Connection
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND TO HAVE A LOOSE CONNECTOR BEFORE PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267250 ↗MalfunctionMay 17, 2026Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT380 ADULT 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 25196844 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER AFTER 12 HOURS OF PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25038440 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER FROM THE CHAMBER BASE AFTER ONE DAY OF PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25038212 ↗MalfunctionApr 28, 2026Crack; Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS LEAKING WATER FROM THE HUMIDIFICATION CHAMBER DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024203 ↗MalfunctionApr 21, 2026Fluid/Blood Leak
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER BETWEEN THE CHAMBER DOME AND BASE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948386 ↗
Other Fisher & Paykel Healthcare Limited products
All Fisher & Paykel Healthcare Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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