Fisher & Paykel Healthcare OPT980Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Mask Interface Adapter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09420012436931), received between Sep 3, 2021 and Aug 7, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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
- Material Split, Cut or Torn5
- Break4
- Material Integrity Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Airway Obstruction1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 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 OPT980 OPTIFLOW + MASK INTERFACE ADAPTER 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 22745915 ↗MalfunctionMar 14, 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 OPT980 OPTIFLOW + MASK INTERFACE ADAPTER WAS FOUND DAMAGED DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16540156 ↗MalfunctionMar 7, 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 OPT980 OPTIFLOW + MASK INTERFACE ADAPTER 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 16498204 ↗MalfunctionJul 14, 2022Break; Therapeutic or Diagnostic Output Failure; Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN MICHIGAN REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT980 OPTIFLOW + MASK INTERFACE ADAPTER WAS FOUND DAMAGED DURING USE AND THE PATIENT DEVELOPED A MUCOUS PLUG. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT WAS TREATED BY THE APPLICATION OF A BAG-VALVE MASK AND SUCTIONING, AND THE SUBJECT OPT980 WAS REPLACED WITH A NEW ONE. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Airway Obstruction
MAUDE report 15010189 ↗MalfunctionFeb 15, 2022Break; Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) THAT THE TUBING OF AN OPT980 OPTIFLOW + MASK INTERFACE ADAPTER WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13538570 ↗MalfunctionJan 24, 2022Material Integrity Problem; Break; Material Integrity Problem
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) VIA A FISHER AND PAYKEL FIELD REPRESENTATIVE (F&P) THAT THE TUBING OF AN OPT980 OPTIFLOW + MASK INTERFACE ADAPTER WAS DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13337965 ↗MalfunctionSep 3, 2021Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT980 OPTIFLOW + MASK INTERFACE ADAPTER WAS BROKEN PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419216 ↗
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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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