Fisher & Paykel Healthcare OPT1044Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow 3S Nasal Cannula- Medium · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09420012435378), received between Apr 29, 2022 and Dec 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Device Slipped1
Patient problems
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN NEW YORK REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING CONNECTION OF AN OPT1044 OPTILFOW 3S NASAL CANNULA HAD DISCONNECTED FROM THE PATIENT INTERFACE DURING USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT WAS ON NASAL HIGH FLOW THERAPY AND THE PATIENT DESATURATED TO A REPORTED SPO2 LEVEL OF 86%. THE HEALTHCARE FACILITY STATED THAT IT WAS POSSIBLE THAT THE TUBING MAY HAVE BEEN PULLED OR CAUGHT DURING THE REPORTED EVENT, AND THAT IT IS POSSIBLE THE PATIENT ATTEMPTED TO REMOVE THE SUBJECT CANNULA.THE HEALTHCARE FACILITY REPORTED THAT THE ONCE THE SUBJECT CANNULA WAS RECONNECTED, THE PATIENT WAS STABILISED. THE HEALTHCARE FACILITY REPORTED NO FURTHER PATIENT CONSEQUENCES.
Patient problems: Low Oxygen Saturation
MAUDE report 23860538 ↗MalfunctionApr 29, 2022Device Slipped; Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE REPORTED THAT THE TUBING OF AN OPT1044 OPTIFLOW ADULT NASAL CANNULA SLIPPED AWAY FROM THE NASAL PRONGS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14247479 ↗
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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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