Fisher & Paykel Healthcare OPT970ERecalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Tracheostomy Direct Connection (Single) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09420012436924), received between Nov 23, 2021 and Jan 16, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break5
- Material Split, Cut or Torn5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR IN CANADA REPORTED VIA A FISHER AND PAYKEL (F&P) FIELD REPRESENTATIVE THAT AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13263091 ↗MalfunctionJan 16, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR IN (B)(6) REPORTED THAT AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13263078 ↗MalfunctionJan 13, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR IN CANADA REPORTED THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13256008 ↗MalfunctionDec 19, 2021Break; Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN (B)(4) REPORTED VIA A FISHER AND PAYKEL (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13040835 ↗MalfunctionNov 23, 2021Break; Material 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 THE TUBING OF AN (B)(4) OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION INTERFACE WAS FOUND BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12866642 ↗
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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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