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
- 2,975
- Deaths
- 34
- Injuries
- 618
- Malfunctions
- 2,323
Reports per year
Source: FDA adverse event reports by year received, 2017–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Ventilator, Continuous, Facility UseCBK2,576
- Ventilator, High FrequencyLSZ195
- Ventilator, Non-Continuous (Respirator)BZD57
- Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI19
- Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE16
- Mixer, Breathing Gases, Anesthesia InhalationBZR16
- Warmer, Thermal, Infusion FluidLGZ11
- Cardiopulmonary Resuscitation Aid KitOEV11
- Humidifier, Respiratory Gas, (Direct Patient Interface)BTT10
- Connector, Airway (Extension)BZA10
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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