Fisher & Paykel Healthcare OPT844Recalls & reported problems
Fisher & Paykel Healthcare Limited · Nasal Cannula for Airvo, MR880 & MR850 Medium · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Fisher & Paykel Optiflow adult nasal cannula, a soft tube used to deliver oxygen. The 39 reports mostly describe tubing found cracked, torn or split, plus hooks breaking or coming loose and parts detaching, generally noticed before or during use with no patient harm mentioned. No deaths or injuries were reported, and 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
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 09420012432124), received between Oct 18, 2018 and Jun 11, 2025 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Break” (24 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
- Break24
- Material Split, Cut or Torn8
- Device Handling Problem6
- Detachment of Device or Device Component4
- Disconnection1
- Gas/Air Leak1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORED THAT THE TUBING OF AN OPT844 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 22181946 ↗MalfunctionMar 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16517018 ↗MalfunctionOct 5, 2022Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15547766 ↗MalfunctionSep 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE HEADGEAR HOOK OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND BROKEN DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15506095 ↗MalfunctionAug 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15223047 ↗MalfunctionJun 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DETACHED FROM THE MANIFOLD DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14725595 ↗MalfunctionJan 19, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13298891 ↗MalfunctionJan 19, 2022Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13298826 ↗MalfunctionJan 11, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) THAT THE TUBING OF AN OPT844 NASAL CANNULA BROKE DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13232430 ↗MalfunctionDec 23, 2021Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6), THAT THE CONNECTOR HOOK OF THE OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13082567 ↗MalfunctionDec 2, 2021Break; Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE CONNECTOR HOOK OF THE OPT844 OPTIFLOW ADULT NASAL CANNULA WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12918923 ↗MalfunctionOct 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(4) THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12677691 ↗MalfunctionOct 14, 2021Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(4), THAT THE CONNECTOR HOOK OF THE OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12637273 ↗MalfunctionOct 12, 2021Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6), THAT THE CONNECTOR HOOK OF THE OPT844 OPTIFLOW ADULT NASAL CANNULA WAS DAMAGED DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12620494 ↗MalfunctionOct 5, 2021Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(4) THAT THE OPT844 OPTIFLOW ADULT NASAL CANNULA BROKE DURING PATIENT USE. IT WAS FURTHER REPORTED THAT THE PATIENT TRIED TO REMOVE THE SUBJECT OPT844 OPTIFLOW ADULT NASAL CANNULA. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12580565 ↗MalfunctionAug 17, 2021Break; Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT ONE SIDE OF THE NASAL INTERFACE OF THE OPT844 OPTIFLOW ADULT NASAL CANNULA WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12334586 ↗MalfunctionJun 15, 2021Break; Break
A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE OPT844 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12005476 ↗MalfunctionApr 21, 2021Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A OPT844 NASAL CANNULA WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11704223 ↗MalfunctionMar 8, 2021Break; Break; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA DISCONNECTED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441199 ↗MalfunctionMar 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA HAD A HOLE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441123 ↗MalfunctionFeb 25, 2021Break; Break
A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE NASAL INTERFACE OF A OPT844 ADULT NASAL CANNULA WAS FOUND BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11381563 ↗MalfunctionFeb 8, 2021Break
A REGULATORY BODY IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF A OPT844 OPTIFLOW ADULT NASAL CANNULA BROKE DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11298946 ↗MalfunctionDec 21, 2020Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS BROKEN DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11052176 ↗MalfunctionDec 21, 2020Break; Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED ON BEHALF OF A DISTRIBUTOR, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE NASAL INTERFACE OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS BROKEN DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11052144 ↗MalfunctionDec 21, 2020Break; Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED ON BEHALF OF A DISTRIBUTOR, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE NASAL INTERFACE OF AN OPT844 OPTIFLOW ADULT NASAL CANNULA WAS BROKEN DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11051995 ↗
Other Cannula, Nasal, Oxygen devices
- Fisher and Paykel Healthcare OPT312Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen22 reports
- Fisher and Paykel Healthcare OPT314Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen17 reports
- O2 Cannula 001366Salter Labs · Cannula, Nasal, Oxygen10 reports
- O2 Cannula 001365Salter Labs · Cannula, Nasal, Oxygen9 reports
- N/A 16SOFT-4Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- N/A 1053-7Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- Fisher & Paykel Healthcare OPT842Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen7 reports
- AirLife™ 001350Vyaire Medical, Inc. · CANNULA, NASAL, OXYGEN5 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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