Fisher & Paykel Healthcare RT202Recalls & reported problems
Fisher & Paykel Healthcare Limited · Adult breathing circuit inspiratory heated with MR290 autofeed chamber · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 09420012430304), received between Jul 29, 2021 and Jan 19, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Crack” (4 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
- Crack4
- Leak/Splash4
- Fluid/Blood Leak2
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2026Crack; Fluid/Blood Leak
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT202 ADULT BREATHING CIRCUIT WAS FOUND LEAKING WATER AFTER 6 DAYS OF PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24110621 ↗MalfunctionDec 18, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT202 ADULT BREATHING CIRCUIT, WAS FOUND CRACKED AND LEAKING WATER FROM THE BOTTOM OF THE CHAMBER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20972799 ↗MalfunctionSep 25, 2024Crack; Leak/Splash; Crack; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER SUPPLIED WITH AN RT202 ADULT BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20298083 ↗MalfunctionJun 5, 2024Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, SUPPLIED WITH A RT202 ADULT BREATHING CIRCUIT WITH MR290 AUTOFEED CHAMBER, WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19473981 ↗MalfunctionDec 19, 2023Leak/Splash; Leak/Splash
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT A RT202 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS FOUND LEAKING FROM THE CONNECTION OF INSPIRATORY CHAMBER PORT. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18361450 ↗MalfunctionJul 17, 2023Leak/Splash; Leak/Splash
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT ELEVEN RT202 ADULT INSPIRATORY HEATED BREATHING CIRCUITS WERE FOUND LEAKING FROM THE CONNECTION OF INSPIRATORY CHAMBER PORT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339745 ↗MalfunctionMay 18, 2022Crack
A DISTRIBUTOR IN COLOMBIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A RT202 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS FOUND CRACKED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14431700 ↗MalfunctionJul 29, 2021Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF THE HEALTHCARE FACILITY IN (B)(6), VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A RT202 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS LEAKING AIR. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12250742 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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