AirLife™ 001365Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Nasal Oxygen Cannula Curved, Flared Tip with 7 foot (2.1 m) Crush-Resistant Tubing and U/Connect-It Adapter Over-the-Ear Style · Class 1
All models of AirLife (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752116696), received between Dec 14, 2023 and Jun 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Disconnection” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Disconnection1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pressure Sore/Ulcer1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
THE REPORT OF A PATIENT DEVELOPING SORES BEHIND THE EARS AND AROUND THE NOSE AFTER USING THE NASAL FLARED W/U-CONNECT-IT CANNULA IS A REPORTABLE INCIDENT. IT WAS REPORTED THAT THE PATIENT'S SORES WERE BEING TREATED BY THE WOUND AND OSTOMY NURSE, INDICATING THAT MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 22188821 ↗InjuryDec 14, 2023Disconnection; Disconnection
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE END THAT CONNECTS TO THE WALL OXYGEN IS MUCH MORE DIFFICULT TO CONNECT TO THE GREEN CHRISTMAS TREE. THE PATIENT EXPERIENCED DESATURATION TO 88%. WHEN THEY LOOKED AT THE 001365 - CANNULA NASAL FLARD W/U-CONNECT-IT, IT HAD DISCONNECTED FROM THE WALL. THEY RECONNECTED THE TUBE TO THE WALL, AND SATURATION INCREASED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18331315 ↗
Other CANNULA, NASAL, OXYGEN devices
- Fisher & Paykel Healthcare OPT844Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen39 reports
- Fisher and Paykel Healthcare OPT312Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen22 reports
- Fisher and Paykel Healthcare OPT314Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen17 reports
- O2 Cannula 001366Salter Labs · Cannula, Nasal, Oxygen10 reports
- O2 Cannula 001365Salter Labs · Cannula, Nasal, Oxygen9 reports
- N/A 16SOFT-4Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- N/A 1053-7Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- Fisher & Paykel Healthcare OPT842Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen7 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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