VYAIRE MEDICAL

Manufacturer adverse-event records for VYAIRE MEDICAL come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2015–2025 · mid-book · elevated Death-code · balanced

Death-code intensity

VYAIRE MEDICAL carries an elevated Death-code share

Death-coded event_type rows are 96 of 9,135 (1.05% · elevated tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for VYAIRE MEDICAL

The standout signal for VYAIRE MEDICAL is Death-code intensity: 1.05% of 9,135 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for VYAIRE MEDICAL. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 7,208 (78.9% of event_type total). Peak single-year volume reaches 2,062 reports across 10 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

9,135
Total Reports
96
Event-type Death
1,831
Injury Reports
20
Device Types

Event Types

Malfunction 7,208 (78.9%)
Injury 1,831 (20.0%)
Death 96 (1.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

7,317 (80.0%)
Required Intervention 1,567 (17.1%)
Other 119 (1.3%)
Death 99 (1.1%)
R 16 (0.2%)
Life Threatening 12 (0.1%)
Hospitalization 10 (0.1%)
L 4 (0.0%)
S 2 (0.0%)
D 1 (0.0%)
O 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

15
2015: 1
17
2017: 2
18
2018: 866
19
2019: 1,824
20
2020: 2,062
21
2021: 1,499
22
2022: 803
23
2023: 1,360
24
2024: 701
25
2025: 17