F&P Optiflow+ OPT944Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Nasal Cannula Medium · Class 2
Quick summary
This Fisher & Paykel Optiflow+ nasal cannula has 389 reports in the FDA database, with 3 injuries and 5 deaths. The reports often describe tubing that is split, cut, or torn, parts that break or come loose, and some mention low blood oxygen levels. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 392
- Deaths reported
- 5
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 392 adverse event reports that list this exact device (DI 09420012429117), received between Feb 19, 2019 and Sep 27, 2026 — classified as 5 deaths, 3 injuries, 384 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (285 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn285
- Break113
- Detachment of Device or Device Component85
- Stretched23
- Leak/Splash7
- Disconnection6
- Crack3
- Gas/Air Leak3
Patient problems
- No Clinical Signs, Symptoms or Conditions348
- Low Oxygen Saturation41
- Insufficient Information4
- Bradycardia1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 392 reports, 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 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 ↗MalfunctionMar 31, 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 24738683 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component; 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 24695120 ↗MalfunctionMar 25, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED 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 24695117 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DETACHED FROM THE 3-WAY CONNECTOR DURING USE. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FOR FURTHER INFORMATION. THE HEALTHCARE FACILITY REPORTED THAT THERE WAS A CRACK AT THE JUNCTION BETWEEN THE NASAL TUBE AND THE CONNECTED OF THE SUBJECT DEVICE. THE SUBJECT DEVICE WAS THEN IMMEDIATELY REPLACED. FURTHERMORE, THE HEALTHCARE FACILITY REPORTED THAT UPON ADMISSION, THE PATIENT'S SPO2 WAS 46%. AFTER ADMINISTERING HIGH-FLOW OXYGEN VIA THE SUBJECT DEVICE, THE PATIENT'S SPO2 INCREASED TO 95%. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT'S VITAL SIGNS REMAINED STABLE AND UNAFFECTED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24554294 ↗MalfunctionMar 4, 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 24508602 ↗MalfunctionFeb 16, 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 24358287 ↗MalfunctionJan 22, 2026Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24142906 ↗MalfunctionJan 4, 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 23954318 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT THE TUBING OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DETACHED FROM THE 3-WAY CONNECTOR DURING USE. UPON REQUEST FOR FURTHER INFORMATION, THE HEALTHCARE FACILITY STATED THAT IT IS UNLIKELY THAT THE SUBJECT OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS PULLED. THE HEALTHCARE FACILITY FURTHER STATED THAT THE OPT944 OPTIFLOW + ADULT NASAL CANNULA COULD HAVE BEEN CAUGHT OR STUCK ON THE EQUIPMENT WHILE MOVING THE PATIENT. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861584 ↗MalfunctionDec 8, 2025Material Split, Cut or Torn; 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 23752187 ↗MalfunctionNov 30, 2025Material Split, Cut or Torn; Material 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 NASAL PRONG OF AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED. 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 23677388 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.