CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling 922 AVEA Ventilators worldwide because an incorrect fuse may fail, causing loss of power to the user interface module.
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 medical device with a potential risk of power loss to the user interface, which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
CareFusion 211 Inc dba Carefusion is recalling 922 units of the AVEA Ventilator, specifically the Gas Delivery Engine (GDE)-refurbished, R16650A. The recall covers 501 units in the United States and the remainder distributed worldwide to countries including Australia, Canada, Japan, and the United Kingdom.
The recall was initiated because the ventilators contain an incorrect F1 fuse on the Transducer Communication Alarm (TCA) Board. This fuse may fail or blow, which can result in a loss of power to the User Interface Module (UIM). The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Manufacturer
- Carefusion 211 Inc dba Carefusion
- Category
- Medical Device — Ventilator
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Carefusion 211 Inc dba Carefusion under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →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
- SevereCareFusion 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
Same hazard · power loss
See all →- HighHumidifier devices recalled because power loss alert sounds under two minutes
FDA (Devices) · 2025-10-22
- HighBD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk
FDA (Devices) · 2025-03-05
- HighBronchoscopic system may lose power due to defective component
FDA (Devices) · 2024-12-25
- High2025 Polestar 3 Vehicles High to Low Voltage Converter Damage Recall
NHTSA · 2024-12-18
- HighZ-800 Infusion System Recalled for Battery Depletion Risk
FDA (Devices) · 2024-11-27