Vyaire V-707254Recalls & reported problems
Jaeger Medical GmbH · Vyntus SPIRO · Class 2
All models of Vyaire (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250892904931), received between Aug 14, 2024 and Oct 31, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Battery Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2024Battery Problem; Battery Problem
THE CUSTOMER COMPLAINED THAT THE BATTERY OF THE DELL LAPTOP IS SWOLLEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577310 ↗MalfunctionAug 14, 2024Battery Problem; Battery Problem
THE CUSTOMER COMPLAINED THAT THE BATTERY OF THE LAPTOP IS SWOLLEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19979215 ↗
Other Calculator, Predicted Values, Pulmonary Function devices
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- Vyaire V-171466-13Jaeger Medical GmbH · Calculator, Predicted Values, Pulmonary Function3 reports
- Vmax 777405-101Carefusion Corporation · Calculator, Predicted Values, Pulmonary Function3 reports
- VMAX 777404-101Vyaire Medical, Inc. · CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION1 report
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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