Fisher & Paykel Healthcare RT302Recalls & reported problems
Fisher & Paykel Healthcare Limited · MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow+ Nasal Cannula · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09420012453204), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 death.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Insufficient Information1
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 15, 2021Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method
A HEALTHCARE FACILITY IN ARKANSAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A RESPIRATORY THERAPIST HAD INCORRECTLY SET UP A TRACHE INTERFACE SYSTEM. THE PATIENT WAS REPORTED TO HAVE PASSED AWAY. THE TRACHE INTERFACE SYSTEM AND ACCESSORIES IS NOT MANUFACTURED BY F&P. HOWEVER, OUR RT302 MICROCELL CIRCUIT KIT ADULT HIFLOW WAS IN USE AT THE TIME. IT WAS ALSO CONFIRMED BY THE HEALTHCARE FACILITY THAT THE INCIDENT WAS A RESULT OF USER ERROR AND THERE WAS NO REPORTED FAULT OF THE RT302 CIRCUIT.
Patient problems: Insufficient Information; Pneumothorax
MAUDE report 11669453 ↗
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- HUDSON RCI IPN046879Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
- HUDSON RCI IPN046880Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
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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