CareFusion AVEA Ventilator Recalled for Pressure Transducer Failure
CareFusion is recalling AVEA ventilators because a pressure transducer failure can stop ventilation. Nonbreathing patients may require manual ventilation or a different device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a critical medical device where failure can cease ventilation for nonbreathing patients, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CareFusion 211 Inc dba CareFusion is recalling CareFusion AVEA ventilators, all models. The recall involves 15,905 units total, with 5,670 units distributed in the US. The devices are distributed worldwide, including in the US, Canada, and numerous other countries.
The recall is due to a potential pressure transducer failure that can activate a false Extended High Ppeak or Circuit Occlusion Alarm. When this occurs, the Safety Valve opens to ambient air and the unit stops ventilating. While spontaneous breathing patients can continue to breathe, the malfunction may delay the initiation of ventilation or cease it entirely. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
Healthcare facilities and users should check their serial numbers against the list provided in the official recall notice. If a device is affected, it should be removed from service and replaced or repaired according to the manufacturer's instructions.
The recalled product
- Product
- CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Manufacturer
- Carefusion 211 Inc dba Carefusion
- Category
- Medical Device — Ventilator
Distribution
Related recalls
Same manufacturer · Carefusion 211 Inc dba Carefusion
See all →- HighCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- CriticalCareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- HighCareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
FDA (Devices) · 2016-06-22
- HighCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- HighCareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
FDA (Devices) · 2016-06-22
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12