Vyaire Medical Inc.
FDA adverse event reports naming Vyaire Medical Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: VYAIRE MEDICAL INC..
- Total reports
- 1,931
- Deaths
- 22
- Injuries
- 309
- Malfunctions
- 1,599
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Ventilator, Continuous, Facility UseCBK1,609
- Ventilator, High FrequencyLSZ198
- Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI33
- Ventilator, Non-Continuous (Respirator)BZD12
- Cardiopulmonary Resuscitation Aid KitOEV9
- Cannula, Nasal, OxygenCAT7
- Catheters, Suction, TracheobronchialBSY6
- Humidifier, Respiratory Gas, (Direct Patient Interface)BTT6
- Mixer, Breathing Gases, Anesthesia InhalationBZR6
- Ventilator, Emergency, Manual (Resuscitator)BTM5
Recent recalls
- 2024-05-08Open, ClassifiedProcess control
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.
Potential of the nozzle separating during patient use.
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