F&P Optiflow+Recalls & reported problems across all models
Fisher & Paykel Healthcare Limited · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 439
- Deaths reported
- 5
- Injuries reported
- 3
- Recalls
- 0
We found 6 models of F&P Optiflow+ by Fisher & Paykel Healthcare Limited in the FDA's device registry (GUDID). Together they are named in 439 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2017 and Sep 27, 2026 — classified as 5 deaths, 3 injuries, 431 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (320 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported F&P Optiflow+ problems
Device problems
- Material Split, Cut or Torn320
- Break123
- Detachment of Device or Device Component91
- Stretched25
- Disconnection8
- Leak/Splash7
- Gas/Air Leak5
- Crack3
Patient problems
- No Clinical Signs, Symptoms or Conditions387
- Low Oxygen Saturation47
- Insufficient Information5
- No Consequences Or Impact To Patient2
- Bradycardia1
- No Known Impact Or Consequence To Patient1
- Pneumonia1
F&P Optiflow+ models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- F&P Optiflow+ OPT944Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- F&P Optiflow+ OPT946Humidifier, Respiratory Gas, (Direct Patient Interface)23 reports
- F&P Optiflow+ OPT942Humidifier, Respiratory Gas, (Direct Patient Interface)18 reports
- F&P Optiflow+ OPT946EHumidifier, Respiratory Gas, (Direct Patient Interface)4 reports
- F&P Optiflow+ OPT942EHumidifier, Respiratory Gas, (Direct Patient Interface)1 report
- F&P Optiflow+ OPT944EHumidifier, Respiratory Gas, (Direct Patient Interface)1 report
Recent F&P Optiflow+ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909708 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
A distributor reported on behalf of a healthcare facility in China that the tubing of an OPT944 Optiflow + Adult Nasal Cannula was found detached from the the 3-way connector during use. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812978 ↗MalfunctionAug 19, 2026Material Split, Cut or Torn
A healthcare facility in China reported via a Fisher and Paykel Healthcare (F&P) field representative that the tubing of an OPT944 Optiflow + Adult Nasal Cannula was found damaged before use.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 50333942 ↗MalfunctionJun 28, 2026Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE CONNECTION BETWEEN THE TUBING AND MANIFOLD OF AN OPT942 OPTIFLOW + ADULT NASAL CANNULA WAS LEAKING AIR BEFORE PATIENT USE. 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 25648496 ↗MalfunctionJun 23, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. 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 25603364 ↗MalfunctionJun 23, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25603262 ↗MalfunctionJun 9, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE AFTER THREE DAYS OF USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25452134 ↗MalfunctionMay 28, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326078 ↗MalfunctionMay 22, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. IT WAS REPORTED BY THE HEALTHCARE FACILITY THAT THE SUBJECT DEVICE WAS IN USE FOR TWO DAYS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25252150 ↗MalfunctionMay 19, 2026Stretched; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. 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 25225246 ↗MalfunctionMay 11, 2026Stretched; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145292 ↗MalfunctionMay 7, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25119276 ↗MalfunctionApr 23, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE INTERFACE OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. 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 24975169 ↗MalfunctionApr 22, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949350 ↗MalfunctionApr 3, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT'S OXYGENATION DECREASED. THE SUBJECT CANNULA WAS THEN REPLACED AND THE PATIENT'S OXYGENATION IMPROVED. THERE WERE NO FURTHER PATIENT CONSEQUENCES REPORTED BY THE HEALTHCARE FACILITY. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FOR FURTHER INFORMATION ABOUT THE REPORTED EVENT, SUCH AS THE SEQUENCE OF EVENTS AND LOCATION OF THE DAMAGED PART OF THE CANNULA. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF F&P'S INVESTIGATION.
Patient problems: Low Oxygen Saturation
MAUDE report 24776304 ↗
Other Fisher & Paykel Healthcare Limited products
All Fisher & Paykel Healthcare Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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