AVEA 3001042Recalls & reported problems
Carefusion Corporation · NASOGASTRIC PRESSURE MONITORING TUBE SET,16FR ADULT · Class 2
All models of AVEA (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846446002683), received between Oct 21, 2019 and Mar 31, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Deliver” (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.
Most reported problems
Device problems
- Failure to Deliver1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LIQUID NUTRIENT WAS FED INTO AN AVEA NASOGASTRIC PRESSURE MONITORING TUBE SET, LIQUID LEAK AT THE BOTTOM END OF THE CLEAR SLEEVE WHICH HOLDS THREE TUBES TOGETHER WAS OBSERVED (THREE TUBES ARE FOR GAS, LIQUID AND PRESSURE MONITORING).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11599999 ↗InjuryOct 21, 2019Failure to Deliver; Failure to Deliver
IT WAS REPORTED TO VYAIRE THAT THE AVEA SMARTCATH NG WAS INSERTED INTO A PATIENT. THE RN WAS UNABLE TO DELIVER MEDICATIONS TO THE PATIENT THROUGH THE NG. THE RN REMOVED THE NG AND IT WAS OBSERVED THAT THERE WERE NO PRIMARY OR SECONDARY HOLES IN THE END OF THE TUBE. THE CUSTOMER ADVISED THE TUBING WAS REPLACED AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9216331 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 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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