Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
CareFusion AVEA ventilator Recalled by Carefusion 211 Inc dba Carefusion Due to A pressure transducer failure can develop, activating a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Carefusion 211 Inc dba Carefusion directly.
Affected Products
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.
Quantity: 15,905 units total (5,670 units in US)
Why Was This Recalled?
A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Carefusion 211 Inc dba Carefusion
Carefusion 211 Inc dba Carefusion has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report