Fisher & Paykel Healthcare OPT970Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Tracheostomy Direct Connection · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Fisher & Paykel Optiflow OPT970 tracheostomy direct connection is tubing that attaches a breathing humidifier to a patient's trach tube. The 43 reports mostly describe the tubing being cracked, split, broken, or coming apart from the connector, sometimes while in use on a patient. No deaths or injuries were reported. There are no recalls for 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
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 09420012436917), received between Dec 4, 2020 and May 22, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (32 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 Torn32
- Break14
- Detachment of Device or Device Component10
- Stretched4
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Low Oxygen Saturation2
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DETACHED FROM THE 3-WAY CONNECTOR DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250998 ↗MalfunctionMar 30, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736593 ↗MalfunctionMar 4, 2026Stretched; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED BEFORE DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508394 ↗MalfunctionMar 3, 2026Stretched; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503221 ↗MalfunctionOct 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING PATIENT USE. IT WAS FURTHER REPORTED BY THE HEALTHCARE FACILITY THAT THE SUBJECT DEVICE WAS IN USE FOR APPROXIMATELY THREE TO FOUR DAYS. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401012 ↗MalfunctionSep 3, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION 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 22949297 ↗MalfunctionJun 4, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION 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 22145316 ↗MalfunctionApr 29, 2025Stretched; Material Split, Cut or Torn; Stretched; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION 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 21931838 ↗MalfunctionMar 9, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES AS THE ISSUE WAS FOUND WHILST THE SUBJECT DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21556184 ↗MalfunctionNov 7, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED AFTER ONE DAY OF USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20636413 ↗MalfunctionOct 25, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION 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 20539735 ↗MalfunctionOct 8, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED AND DETACHED AFTER ONE HOUR OF USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20404456 ↗MalfunctionMay 27, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION 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 19402401 ↗MalfunctionJan 31, 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 THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGE AS A RESULT OF BEING PULLED BY THE PATIENT DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18620096 ↗MalfunctionAug 2, 2023Stretched; Material Split, Cut or Torn; Stretched; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION 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 17446402 ↗MalfunctionMar 23, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16606479 ↗MalfunctionMar 23, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16606434 ↗MalfunctionJan 15, 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 OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION 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 16172280 ↗MalfunctionDec 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE AFTER FIVE DAYS OF USE THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DETACHED FROM 3-WAY CONNECTOR. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15956416 ↗MalfunctionDec 8, 2022Detachment 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 THE TUBING OF AN OPT970 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15947080 ↗MalfunctionDec 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING USE. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE PATIENT DESATURATED, THE SUBJECT DEVICE WAS REPLACED AND THE PATIENT RECOVERED. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 15928314 ↗MalfunctionJun 17, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14725754 ↗MalfunctionJun 2, 2022Break; Material 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 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 14583009 ↗MalfunctionMay 4, 2022Break; Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(4) THAT THE TUBING OF A OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS DAMAGED DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14275164 ↗MalfunctionApr 25, 2022Break; Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE TUBING OF AN OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION WAS FOUND DAMAGED DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14198070 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
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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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