Fisher and Paykel Healthcare OPT314Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 09420012432285), received between May 22, 2022 and May 15, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Break; Detachment of Device or Device Component

  A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED FROM THE CANNULA END DURING USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED TO CONTINUE THERAPY AND THAT THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179887 ↗
• MalfunctionMar 31, 2026Break; Detachment of Device or Device Component

  A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750337 ↗
• MalfunctionMar 13, 2026Break

  A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED DURING USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED TO CONTINUE THERAPY AND THAT THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587752 ↗
• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF THE OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM CANNULA END DURING USE. THE HEALTHCARE FACILITY REPORTED A TEMPORARY DROP IN THE PATIENT'S OXYGEN SATURATION. IT WAS ALSO REPORTED THAT THE SUBJECT DEVICE WAS IMMEDIATELY REPLACED TO CONTINUE THE THERAPY, WITH NO FURTHER REPORTED PATIENT CONSEQUENCES.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24450986 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF THE OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM CANNULA END DURING USE. IT WAS ALSO REPORTED THAT THE SUBJECT DEVICE WAS IMMEDIATELY REPLACED TO CONTINUE THE THERAPY, WITH NO FURTHER REPORTED PATIENT CONSEQUENCES.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24450934 ↗
• MalfunctionAug 21, 2025Break; Break

  A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS BROKEN CAUSING AIR LEAK AFTER USING THE CANNULA FOR AROUND 48 HOURS. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE CANNULA MIGHT HAVE DAMAGED DURING USE, CAUSING AIR LEAK. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THE SUBJECT CANNULA WAS REPLACED TO MAINTAIN THE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858431 ↗
• MalfunctionJul 3, 2025Break; Break

  A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS BROKEN DURING USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THE SUBJECT CANNULA WAS REPLACED AND THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401453 ↗
• MalfunctionJun 17, 2025Break; Break

  A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS BROKEN DURING USE ON A PATIENT. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT EXPERIENCED RAPID BREATHING AND LOW OXYGEN SATURATION FOR THIRTY SECONDS BEFORE THE CANNULA WAS REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: Hypoxia

  MAUDE report 22256864 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A HEALTHCARE FACILITY IN (B)(6) HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL 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 22024872 ↗
• MalfunctionJan 9, 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 AN OPT314 OPTIFLOW JUNIOR NASAL CANNULA CAME OFF FROM THE CANNULA JOINT WHAN TAKEN OUT OF THE PACKAGE. 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 21121056 ↗
• MalfunctionDec 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED FROM THE CANNULA TUBE JOINT. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT EXPERIENCED A TEMPORARY DESATURATION, AND THE CONDITION WAS STABILIZED UPON INCREASING THE OXYGEN FLOW AND IMMEDIATELY REPLACING THE CANNULA. THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21014931 ↗
• MalfunctionDec 15, 2024Break; Break

  A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR INFANT NASAL CANNULA WAS BROKEN AT SWIVEL GRIP TUBE JOINT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20934526 ↗
• MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA'S TUBING WAS DETACHED FROM THE SWIVEL GRIP JOINT. IT WAS FURTHER REPORTED THAT THE FAILURE WAS IDENTIFIED DUE TO THE PATIENT'S TACHYPNOEA. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154063 ↗
• MalfunctionMar 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN OPT314 OPTIFLOW JUNIOR 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 18899508 ↗
• MalfunctionFeb 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A HEALTHCARE FACILITY IN GERMANY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, REPORTED THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM THE SWIVEL GRIP JOINT DURING PATIENT USE. IT WAS REPORTED THAT THE INCIDENT WAS NOTICED AFTER THE PATIENT'S OXYGEN SATURATION DROPPED. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED ABOUT THE LEVEL OF DESATURATION.

  Patient problems: Insufficient Information

  MAUDE report 16455864 ↗
• MalfunctionJun 2, 2022Material Integrity Problem; Material Integrity Problem

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6), THAT THE WIGGLE PADS OF AN OPT314 OPTIFLOW JUNIOR NASAL CANNULA WERE NOT STICKING DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578731 ↗
• MalfunctionMay 22, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A DISTRIBUTOR IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT AN OPT314 OPTIFLOW JUNIOR CANNULA WAS DAMAGED DURING USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467543 ↗