F&P Evaqua 2 RT265Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 09420012430205), received between Mar 9, 2017 and Sep 21, 2026 — classified as 2 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (48 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 1, 2026Loose or Intermittent Connection

  A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS REPORTED TO HAVE A LOOSE CONNECTION. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761167 ↗
• MalfunctionMar 30, 2026Gas/Air Leak; Material Integrity Problem

  A HEALTHCARE FACILITY IN ITALY REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND DAMAGED DURING PATIENT USE, CAUSING AN AIR LEAK. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709150 ↗
• MalfunctionMar 9, 2026Gas/Air Leak

  A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552160 ↗
• MalfunctionFeb 18, 2026Gas/Air Leak

  A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT AN RT265 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 24381597 ↗
• MalfunctionFeb 12, 2026Crack; Gas/Air Leak

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT A 'SMALL CRACK' WAS FOUND ON AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT. THERE WAS NO PATIENT HARN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328939 ↗
• MalfunctionFeb 12, 2026Gas/Air Leak

  A HEALTHCARE FACILITY IN JAPAN REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN RT265 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 24328938 ↗
• MalfunctionJan 6, 2026Gas/Air Leak

  A HEALTHCARE FACILITY IN THE JAPAN REPORTED THAT AN RT265 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 23985334 ↗
• MalfunctionDec 11, 2025Gas/Air Leak; Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SOUTH AFRICA THAT AN RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783891 ↗
• MalfunctionDec 3, 2025Crack; Crack

  A HEALTHCARE FACILITY IN GREECE REPORTED, THROUGH A FISHER & PAYKEL (F&P) HEALTHCARE SALES REPRESENTATIVE, THAT SEVEN RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE FOUND TO HAVE CRACKED AROUND THE ELBOW CONNECTOR ON THE EXPIRATORY LIMB. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711905 ↗
• MalfunctionDec 3, 2025Leak/Splash; Leak/Splash

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS REPORTED TO BE LEAKING NEAR THE CHAMBER BASE DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709110 ↗
• MalfunctionNov 30, 2025Leak/Splash; Leak/Splash

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS REPORTED TO BE LEAKING BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677320 ↗
• MalfunctionNov 17, 2025Gas/Air Leak; Gas/Air Leak

  A DISTRIBUTOR IN COLOMBIA REPORTED, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN RT265 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 23577183 ↗
• MalfunctionNov 11, 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 AN RT265 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 23529154 ↗
• MalfunctionOct 27, 2025Gas/Air Leak; 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 RT265 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 23399432 ↗
• MalfunctionOct 8, 2025Gas/Air Leak; Gas/Air Leak

  A HEALTHCARE FACILITY IN SWITZERLAND REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT TWO RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS WERE NOT SECURELY FITTED TO THE VENTILATOR. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23248990 ↗
• MalfunctionSep 11, 2025Gas/Air Leak; 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 RT265 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 23034312 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; 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 RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT, WAS FOUND LEAKING WATER DURING PATIENT USE. THE LEAK LOCATION WAS IDENTIFIED TO BE THE CONNECTION BETWEEN THE CHAMBER DOME AND CHAMBER BASE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010765 ↗
• MalfunctionJul 29, 2025Connection Problem; Connection Problem

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT A 900MR869 TEMPERATURE/FLOW PROBE DISLODGED FROM THE PATIENT-END TEMPERATURE PROBE PORT OF TWO RT265 INFANT EVAQUA2 BREATHING CIRCUITS DURING SET UP AND PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22660398 ↗
• MalfunctionJun 12, 2025Gas/Air Leak; Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN MEXICO THAT AN RT265 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 22199976 ↗
• MalfunctionJun 12, 2025Gas/Air Leak; Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN MEXICO THAT AN RT265 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 22199975 ↗
• MalfunctionJun 11, 2025Leak/Splash; Leak/Splash

  A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT A MR290V AUTOFEED HUMIDIFICATION CHAMBER AS PART OF THE RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING FROM THE DOME. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191312 ↗