Fisher & Paykel Healthcare RT330Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 09420012431066), received between Jul 31, 2017 and Sep 28, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K020332); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2025Gas/Air Leak; Gas/Air Leak

  A HEALTHCARE FACILITY IN TAIWAN REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN RT330 OPTIFLOW TUBING KIT WAS FOUND LEAKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164011 ↗
• MalfunctionSep 21, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS A PART OF AN RT330 OPTIFLOW TUBING KIT WAS LEAKING WATER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106371 ↗
• MalfunctionSep 9, 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 RT330 OPTIFLOW TUBING KIT WAS LEAKING WATER BETWEEN THE BASE AND THE DOME OF THE CHAMBER BEFORE PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009518 ↗
• MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR IN COLOMBIA REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT330 OPTIFLOW TUBING KIT, WAS LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683611 ↗
• MalfunctionJul 29, 2025Gas/Air Leak; Gas/Air Leak

  A DISTRIBUTOR IN COLOMBIA REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN RT330 OPTIFLOW TUBING KIT GENERATED A LEAK ALARM. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22651968 ↗
• MalfunctionFeb 19, 2025Crack; Material Puncture/Hole; Material Integrity Problem; Crack; Material Puncture/Hole; Material Integrity Problem

  A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT330 OPTIFLOW TUBING KIT HAD A 'TEAR' IN THE CHAMBER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417661 ↗
• MalfunctionAug 20, 2024Leak/Splash; Leak/Splash

  A HEALTHCARE FACILITY IN TAIWAN REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS PART OF AN RT330 ADULT OPTIFLOW TUBING KIT, WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005042 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS PART OF AN RT330 OPTIFLOW TUBING KIT, WAS FOUND LEAKING WATER PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001612 ↗
• MalfunctionJul 18, 2024Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT A RT330 OPTIFLOW TUBING KIT WAS FOUND BROKEN PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779989 ↗
• InjuryOct 10, 2023Leak/Splash; Leak/Splash

  A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A PATIENT WAS BEING ASSESSED FOR UNEXPLAINED DESATURATIONS (TO 70% SPO2). THE PATIENT WAS TRANSFERRED TO PICU WHERE IT WAS IDENTIFIED THAT THE MAXTEC OXYGEN ANALYSER WAS LEAKING AND " FALLING OUT FREQUENTLY" WHEN CONNECTED TO THE RT330 OPTIFLOW JUNIOR TUBING KIT. THERE WAS NO PATIENT HARM REPORTED. THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17909864 ↗
• MalfunctionApr 18, 2023Component Missing; Component Missing

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, THAT THE BLUE CAP OF A PRESSURE RELIEF VALVE FROM A RT330 OPTIFLOW JUNIOR TUBING KIT WAS FOUND MISSING BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16759667 ↗
• MalfunctionMar 1, 2023Gas/Air Leak; Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE PRESSURE RELIEF VALVE OF A RT330 OPTIFLOW JUNIOR TUBING KIT WAS FOUND LEAKING BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464826 ↗
• MalfunctionAug 8, 2022Fluid/Blood Leak; Leak/Splash; Leak/Splash

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE CHAMBER ADAPTER CONNECTION OF A RT330 OPTIFLOW JUNIOR TUBING KIT WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189293 ↗
• MalfunctionApr 20, 2022Gas/Air Leak; Device Slipped; Gas/Air Leak

  A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TEMPERATURE PROBE WAS "POPPING OUT" OF THE INSPIRATORY LIMB OF A RT330 OPTIFLOW JUNIOR TUBING KIT DURING USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164003 ↗
• MalfunctionJan 12, 2022Melted

  A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE TUBING OF A RT330 OPTIFLOW JUNIOR TUBING KIT MELTED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237470 ↗
• MalfunctionOct 5, 2021Fluid/Blood Leak; Fluid/Blood Leak; Leak/Splash

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT "THERE WAS A WATER LEAK FROM THE RT330 CIRCUIT NEAR THE CONNECTOR TO THE CHAMBER PORT" DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579306 ↗
• MalfunctionJul 31, 2017Occlusion Within Device; Occlusion Within Device

  A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE PATIENT END CONNECTOR OF THE RT330 OPTIFLOW JUNIOR TUBING KIT HAD AN OCCLUSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6756174 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020332. One submission often covers many models, so check the product and lot details in each record.

• Z-0553-05 · Dec 21, 2004 · Terminated
  RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.