3100A HFOVRecalls & reported problems across all models
Vyaire Medical, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 8 models of 3100A HFOV by Vyaire Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2021 and Nov 4, 2025 — classified as 21 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported 3100A HFOV problems
Device problems
- Material Too Soft/Flexible11
- Disconnection6
- Improper Flow or Infusion6
- Mechanical Problem6
- Device Emits Odor4
- Loose or Intermittent Connection3
- No Device Output3
- Unexpected Shutdown3
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information6
- Low Oxygen Saturation4
- Bradycardia3
- Hypoventilation1
3100A HFOV models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3100A HFOV 768901VENTILATOR, HIGH FREQUENCY30 reports
- 3100A HFOV 29028-011VENTILATOR, HIGH FREQUENCY9 reports
- 3100A HFOV 29028-004VENTILATOR, HIGH FREQUENCY6 reports
- 3100A HFOV 29028-003VENTILATOR, HIGH FREQUENCY6 reports
- 3100A HFOV 768901-RFBVENTILATOR, HIGH FREQUENCY1 report
- 3100A HFOV 11518-850SVENTILATOR, HIGH FREQUENCY1 report
- 3100A HFOV 771465VENTILATOR, HIGH FREQUENCY1 report
- 3100A HFOV 29028-012VENTILATOR, HIGH FREQUENCY1 report
Recent 3100A HFOV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BEFORE USE, THE DEVICE WAS EXPERIENCING O2 LEAKAGE FAILURE AND THE LOCKING TAB ON POWER KNOB IS NON-FUNCTIONAL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467100 ↗MalfunctionOct 23, 2025Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE DRIVER WOULD NOT START. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368263 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE VENTILATOR HAD WATER IN THE GREEN TUBING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301788 ↗MalfunctionOct 15, 2025Device Emits Odor; Smoking; Device Emits Odor; Smoking
IT WAS REPORTED THAT THE DEVICE HAS BEEN PLUGGED AND HAS ELECTRICAL BURNS AND SMELL. THERE IS NO PHYSICAL DAMAGE NOR BURN MARKS ON THE UNIT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 23285266 ↗MalfunctionOct 15, 2025Device Emits Odor; Smoking; Device Emits Odor; Smoking
IT WAS REPORTED THAT A BURNT SMELL WAS OBSERVED COMING FROM THE DEVICE WHILE BEING USED ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285084 ↗MalfunctionOct 6, 2025Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE VENT IS NOT WORKING WHILE ON A PATIENT AND IS LOSING PRESSURE WHEN DROPPING BELOW 10CM H20. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23227614 ↗MalfunctionOct 6, 2025No Device Output; No Device Output
THE CUSTOMER REPORTED THAT THE UNIT WILL BE PRESSURIZED BUT FAILS TO START. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23227589 ↗MalfunctionOct 6, 2025Pressure Problem; Pressure Problem
IT WAS REPORTED THAT UPON SET UP, THE PISTON CENTERING DISPLAY COULD NOT BE SEEN AND THE MAP WOULD NOT HOLD PRESSURE ON THE DEVICE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23227537 ↗MalfunctionOct 3, 2025Failure to Cycle; Failure to Cycle
IT WAS REPORTED THAT THE DRIVER ON THE DEVICE STOPPED WORKING TWICE WHILE BEING USED ON A PATIENT. ANOTHER DEVICE WAS USED. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23210006 ↗MalfunctionSep 29, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE POWER AMPLITUDE DISPLAY OF THE DEVICE IS NOT WORKING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23166492 ↗MalfunctionSep 29, 2025Failure to Cycle; Failure to Cycle
IT WAS REPORTED THAT THE DRIVER WILL NOT START WHEN PRESSING THE START/STOP BUTTON WHEN THE UNIT IS PRESSURIZED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23166476 ↗MalfunctionSep 25, 2025Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR WILL NOT PRESSURIZE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23145683 ↗MalfunctionSep 9, 2025Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT BEFORE USE, THERE WAS A BURNING SMELL WHEN THE DEVICE WAS POWERED ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004672 ↗MalfunctionAug 26, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S PISTON WOULDN'T START AND FAILED TO CYCLE/OSCILLATE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22893847 ↗MalfunctionAug 26, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S PISTON WOULDN'T START AND FAILED TO CYCLE/OSCILLATE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22893825 ↗
Other Vyaire Medical, Inc. products
All Vyaire Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page