Fisher & Paykel Healthcare OPT964Recalls & reported problems
Fisher & Paykel Healthcare Limited · Nasal Cannula - Medium · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09420012469564), received between Jan 21, 2025 and Nov 6, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn4
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Low Oxygen Saturation2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CANADA REPORTED, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT AN OPT964 OPTIFLOW + DUET ASYMMETRICAL NASAL CANNULA WAS FOUND TO BE DAMAGED AND LEAKING AIR DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493860 ↗MalfunctionMar 18, 2025Stretched; Material Split, Cut or Torn; Stretched; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT964 OPTIFLOW + DUET ASYMMETRICAL NASAL CANNULA WAS FOUND DEFORMED AND LEAKING DURING PATIENT USE. THE HEALTHCARE FACILITY STATED THAT THE SUBJECT DEVICE HAD BEEN IN USE FOR A FEW MINUTES. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT STARTED TO DESATURATE. THE SUBJECT DEVICE WAS THEN REPLACED, AND THE PATIENT RECOVERED. THERE WAS NO FURTHER PATIENT CONSEQUENCE REPORTED. FISHER & PAYKEL HEALTHCARE (F&P) HAVE REQUESTED FURTHER INFORMATION ABOUT THE REPORTED EVENT. HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. F&P WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
Patient problems: Low Oxygen Saturation
MAUDE report 21639081 ↗MalfunctionJan 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT964 OPTIFLOW + DUET ASYMMETRICAL NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. THE HEALTHCARE FACILITY STATED THAT THE CANNULA TUBING HAD SPLIT. 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 21203579 ↗MalfunctionJan 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 23 DECEMBER 2024, A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT964 OPTIFLOW + DUET ASYMMETRICAL NASAL CANNULA WAS FOUND DAMAGED AND LEAKING DURING PATIENT USE. THE HEALTHCARE FACILITY LATER STATED ON (B)(6) 2025 THE PATIENT WAS IN PALLIATIVE CARE FOR RESPIRATORY FAILURE SECONDARY TO INTERSTITIAL LUNG DISEASE AND HAD DESATURATED DURING THE EVENT TO APPROXIMATELY 60% SPO2. THE PATIENT WAS PLACED ON A NON-REBREATHER MASK AND THERAPY WAS RESTARTED WITH A NEW DEVICE. THE HEALTHCARE FACILITY STATED THE PATIENT'S SPO2 IMPROVED AND THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES.
Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions
MAUDE report 21200816 ↗
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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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