Fisher and Paykel Healthcare OPT318Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Junior Pediatric Nasal Cannula · Class 2
All models of Fisher and Paykel Healthcare (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Fisher & Paykel Optiflow Junior pediatric nasal cannula, a breathing tube for children. The 32 reports mostly describe the tubing breaking, splitting or coming apart at the connector end during use, with the cannula replaced. 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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 09420012432308), received between Jul 29, 2021 and Apr 24, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
- Break18
- Material Split, Cut or Torn13
- Detachment of Device or Device Component11
Patient problems
- No Clinical Signs, Symptoms or Conditions31
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Break
A HEALTHCARE FACILITY IN CHINA REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS BROKEN DURING USE. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24977723 ↗MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OPT318 OPTIFLOW JUNIOR PEDIATRIC NASAL CANNULA DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846921 ↗MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF THE OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP) DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835200 ↗MalfunctionJul 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED THAT THE TUBING OF TWO OPT318 OPTIFLOW JUNIOR NASAL CANNULAS WERE DETACHED FROM THE CONNECTOR END (SWIVEL GRIP) DURING USE ON A PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22605864 ↗MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, THAT THE TUBING OF AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM THE CANNULA. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22516426 ↗MalfunctionJun 25, 2025Break; Break
A CUSTOMER IN BRAZIL REPORTED VIA THE ANVISA REPORTING SYSTEM THAT THE OPT318 OPTIFLOW JUNIOR INFANT NASAL CANNULA'S INTERFACE WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333760 ↗MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT318 OPTIFLOW JUNIOR INFANT NASAL CANNULA WAS DETACHED FROM THE CANNULA TUBE JOINT DURING USE ON A PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21940403 ↗MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OPT318 OPTIFLOW JUNIOR INFANT NASAL CANNULA WAS DETACHED DURING USE ON A PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21896858 ↗MalfunctionMar 17, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN BRAZIL VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21627751 ↗MalfunctionJan 30, 2025Break; Break
A HEALTHCARE FACILITY IN CHINA REPORTED VIA THE NMPA REPORTING SYSTEM THAT THE OPT318 OPTIFLOW JUNIOR INFANT NASAL CANNULA'S INTERFACE WAS BROKEN DURING USE ON A PATIENT THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT WAS SWITCHED FROM HIGH-FLOW OXYGEN THERAPY TO MEDIUM-FLOW OXYGEN THERAPY. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21280127 ↗MalfunctionDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED AT THE SWIVEL TUBE JOINT BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20860210 ↗MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN BRAZIL REPORTED THAT AN OPT318 OPTIFLOW JUNIOR INFANT NASAL CANNULA WAS BROKEN DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20355954 ↗MalfunctionSep 15, 2024Material 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 OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND DAMAGED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20221355 ↗MalfunctionJul 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19662597 ↗MalfunctionJun 26, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19621139 ↗MalfunctionFeb 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
AN ANONYMOUS CUSTOMER IN BRAZIL REPORTED VIA THE ANVISA SYSTEM THAT THE OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS PIERCED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18717970 ↗MalfunctionDec 21, 2023Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND TO BE BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18379930 ↗MalfunctionDec 5, 2023Break; Break
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND TO BE BROKEN ON ONE SIDE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18271877 ↗MalfunctionAug 15, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, IN BRAZIL, THAT AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA HAD BROKEN. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17548692 ↗MalfunctionMar 13, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT TUBING OF AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS CRACKED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16531216 ↗MalfunctionMar 13, 2023Break; Break
A HEALTHCARE FACILITY IN WASHINGTON REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT318 OPTIFLOW JUNIOR CANNULA WAS DETACHED FROM THE SWIVEL GRIP JOINT DURING USE ON A PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16531215 ↗MalfunctionJan 15, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT TUBING OF AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS CRACKED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16172241 ↗MalfunctionDec 19, 2022Break; Break
A HEALTHCARE FACILITY IN TURKEY REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE REPRESENTATIVE THAT THE TUBING OF 3 OPT318 OPTIFOLOW JUNIOR NASAL CANNULAS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16011110 ↗MalfunctionNov 23, 2022Break; Break
A DISTRIBUTOR IN CHINA REPORTED BEHALF OF A HEALTHCARE FACILITY THAT THE OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS BROKEN BETWEEN THE NASAL PRONGS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15859525 ↗MalfunctionNov 23, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR ON BEHALF OF A HEALTHCARE FACILITY IN THAILAND REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE REPRESENTATIVE THAT LEAKS WERE FOUND IN TUBING OF THREE OPT318 OPTIFLOW JUNIOR NASAL CANNULAS BEFORE USE ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15858564 ↗
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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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