VELARecalls & reported problems across all models
Vyaire Medical, Inc. · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 9 models of VELA by Vyaire Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Dec 30, 2021 and Oct 2, 2024 — classified as 8 injuries, 58 malfunctions.
The most frequently reported specific device problem is “Failure to Calibrate” (25 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 VELA problems
Device problems
- Failure to Calibrate25
- No Device Output8
- Failure to Recalibrate7
- Mechanical Problem7
- No Display/Image3
- Failure to Conduct2
- Failure to Deliver2
- Gas Output Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Insufficient Information2
VELA models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VELA 16600Ventilator, continuous, facility use30 reports
- VELA 16532-00Ventilator, continuous, facility use14 reports
- VELA 16530-12Ventilator, continuous, facility use7 reports
- VELA 16532-12Ventilator, continuous, facility use5 reports
- VELA 16531-12Ventilator, continuous, facility use4 reports
- VELA 16532-07Ventilator, continuous, facility use2 reports
- VELA 16531-00Ventilator, continuous, facility use2 reports
- VELA R16532-00Ventilator, continuous, facility use1 report
- Vela 16530-00Ventilator, Continuous, Facility Use1 report
Recent VELA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT LOW VOLUME WHEN SET AT 500, BUT UNIT IS GIVING 227. UNKNOWN PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20352833 ↗MalfunctionOct 2, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA HAD PERSISTENT XDCR (TRANSDUCER) FAULT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20352477 ↗MalfunctionSep 17, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL LOW VTE AND LEAK. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20237937 ↗MalfunctionSep 13, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THAT VENT INOP/MOTOR FAULT ALARMED, AND THE DEVICE WAS NOT VENTILATING. UNKNOWN PATIENT INVOLVEMENT
Patient problems: Insufficient Information
MAUDE report 20212904 ↗InjurySep 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENT HAD NO DISPLAY AND NOT VENTING. WHEN TURNING ON THE VENT, THE DISPLAY FLASHES ON THEN GOES BLACK. PATIENT INVOLVED. HOWEVER, NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20193057 ↗MalfunctionJul 16, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED VYAIRE MEDICAL: TRANSUCER (XDCR) FAULT OCCURRED DURING USAGE ON A PATIENT. THERE WAS NOT INJURY OR HARM TO THE PATIENT. MEDICAL INTERVENTION WAS NOT REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19751972 ↗MalfunctionJul 12, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL: A TRANSDUCER FAULT OCCURRED ON THE VELA VENTILATOR DUE TO SWAPPING THE MAIN BOARD DUE TO PERSISTENT TRANSDUCER FAULTS WHILE ON A PATIENT. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19730386 ↗MalfunctionJul 9, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL: A MOTOR FAULT DEFECTIVE MOTOR BOARD WAS NOTED ON THE VELA VENTILATOR. CURRENTLY, PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19701273 ↗MalfunctionJun 20, 2024Gas Output Problem; Gas Output Problem
IT WAS REPORTED TO VYAIRE MEDICAL, THE CUSTOMER WAS UNABLE TO ACHIEVE SUFFICIENT RESPIRATORY VOLUME; ALTHOUGH THE TURBINE WAS RUNNING, THE RESPIRATORY VOLUME WAS TOO LOW. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578241 ↗MalfunctionJun 20, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL, THE CUSTOMER IS REQUESTING A PO FOR A MAIN BOARD AND TURBINE DUE TO TRANSDUCER FAULT CAUSING THE VELA VENTILATOR TO NOT CYCLE. ORDER WAS PROCESSED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19577090 ↗MalfunctionJun 20, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL, THE EXHALATION DIFF TRANSDUCER WAS FAILING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19577016 ↗MalfunctionJun 18, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A "TRANSDUCER FAULT" OCCURRED ON THE VELA VENTILATOR WHILE ON A PATIENT. NO PATIENT HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19558116 ↗MalfunctionJun 17, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A TRANSDUCER FAULT OCCURRED ON THE VELA VENTILATOR DURING MAINTENANCE WORK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19554428 ↗MalfunctionJun 17, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A "TRANSDUCER FAULT". OCCURRED WITH THE VELA VENTILATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19548118 ↗MalfunctionJun 17, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL A "TRANSDUCER FAULT." OCCURRED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19548069 ↗
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.
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