F&P Optiflow+ OPT942Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 09420012428493), received between Jan 28, 2021 and Jun 28, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (14 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN BRAZIL VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT942 OPTIFLOW + NASAL CANNULA WAS FOUND TORN NEAR THE CONNECTOR. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329343 ↗
• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT942 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 23092734 ↗
• MalfunctionApr 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 OPT942 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DETACHED FROM THE 3-WAY CONNECTOR 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 21802460 ↗
• MalfunctionNov 6, 2024Disconnection; Disconnection

  ON 7 OCTOBER 2024 A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT ON (B)(6) 2024 THE MANIFOLD OF A OPT942 OPTIFLOW + ADULT NASAL CANNULA HAD BECOME DISCONNECTED FROM THE PATIENT INTERFACE DURING USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT WAS SETTLED WHEN THEY WERE SEEN BY A STAFF MEMBER AT 5:30PM AND THAT AT 6PM THE PATIENT WAS FOUND UNRESPONSIVE AND THAT THE OPT942 OPTIFLOW + ADULT NASAL CANNULA WAS DISCONNECTED AT THE MANIFOLD. IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY AND THE CAUSE OF DEATH WAS FOOD ASPIRATION IN COMBINATION WITH BRONCHOPNEUMONIA AND THAT THEY ALSO HAD SYSTEMIC HYPERTENSION AND CHRONIC LEG ULCERS. IT WAS ALSO REPORTED THAT THE PATIENT WAS ON AMBER CARE AND HAD A DNAR ORDER IN PLACE. THERE WAS NO PATIENT MONITORING IN PLACE AS THE HEALTHCARE FACILITY REPORTED THAT ITS TELEMETRY WAS NOT WORKING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616623 ↗
• MalfunctionOct 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT942 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT DESATURATED TO A SPO2 OF 85%, AND THAT ONCE THE SUBJECT DEVICE WAS IMMEDIATELY REPLACED THE PATIENT RECOVERED TO A SPO2 OF 98%. THERE WERE NO FURTHER PATIENT CONSEQUENCES REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20436615 ↗
• MalfunctionSep 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT942 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 20133783 ↗
• MalfunctionMay 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN TAIWAN REPORTED VIA A FISHER AND PAYKEL (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT942 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 16908674 ↗
• MalfunctionMar 28, 2023Material 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 OPT942 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633097 ↗
• MalfunctionMar 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT942 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 16506346 ↗
• MalfunctionFeb 20, 2023Detachment 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 HEALTHCARE FACILITY IN THAILAND VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT942 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 16405943 ↗
• MalfunctionFeb 2, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN THE (B)(6) REPORTED VIA A FISHER AND PAYKEL (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT942 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286066 ↗
• MalfunctionNov 22, 2022Stretched; Material Split, Cut or Torn; Stretched; Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT942 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 15845944 ↗
• MalfunctionAug 25, 2022Material 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 OPT942 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 15299464 ↗
• MalfunctionAug 11, 2022Break; Material Split, Cut or Torn; Material Split, Cut or Torn

  A DISTRIBUTOR IN COLOMBIA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT942 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215092 ↗
• MalfunctionJul 14, 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 TUBING OF AN OPT942 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DETACHED FROM THE 3-WAY CONNECTOR DURING USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15024510 ↗
• MalfunctionJun 22, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE INTERFACE OF AN OPT942 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 14783974 ↗
• MalfunctionJan 28, 2021Material 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 OPT942 OPTIFLOW ADULT NASAL CANNULA BROKE DURING TWO DAYS OF USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11246963 ↗