Baxter Healthcare Corp recalls certain Volara system single-patient use circuits and blue ventilator adapter assemblies due to disconnection risk that may prevent proper ventilation.

RT’s Three Key Takeaways

  1. Baxter is recalling certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to the risk of the handset plug disconnecting from the nebulizer port, which could result in inadequate ventilation for patients.
  2. The FDA has classified this recall as a Class I, the most serious type, as the disconnection may lead to severe health consequences, including oxygen desaturation, brain injury, heart attack, respiratory failure, or death.
  3. Baxter has advised users to stop using the affected products, return them, and await replacement units while providing specific instructions for patients who have no other therapy options.


Baxter is recalling certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the handset plug within these components may disconnect from the nebulizer port on the blue ventilator adapter, according to an FDA alert.

The FDA reports that, when using the Volara system in-line with a ventilator and without a nebulizer connected to the blue ventilator adapter, the handset plug is required for proper operation and gas flow. If the plug is disconnected, the ventilator may not provide enough ventilation to the patient.

The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold.

The FDA says use of affected product may cause serious adverse health consequences including a decrease in oxygen levels (desaturation) that can lead to injuries from lack of oxygen such as brain injury, heart attack, respiratory failure and death.

There have been no reported injuries or deaths, according to the FDA alert.

Affected Product

  • Product Names: Volara System Single Patient Use Circuit and Blue Ventilator Adapter (sold separately from Volara System)
  • Unique Device Identifier (UDI)/Product Codes:
    • Single-patient use circuit: M08473, M08474
    • Blue Ventilator Adapter Assembly: M07937 

What to Do

  • Do not use affected patient circuits.
  • If a patient has no other option for therapy, continue to use with caution.
    • Visually inspect the nebulizer port prior to therapy
    • Check for any ventilator gas flow leaks throughout therapy

On May 30, 2024, Baxter sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:

  • Stop use of all affected lot numbers.
  • Return all affected units.
  • Notify others who may have received affected product.
  • Complete and return the acknowledgement form included in the letter.

Replacement products (Blue Ventilator Adapter module) will be shipped to the user along with instructions about how to return the affected products.

Reason for Recall

Baxter is recalling certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the handset plug within these components may disconnect from the nebulizer port on the blue ventilator adapter.

Device Use

The Volara System is intended for use with patients who are using a ventilator to help them breathe. The system helps expand airways, treat and prevent lung consolidation and atelectasis, as well as move and treat mucous and other airway secretions. It is attached to the ventilator circuit tubes between the patient and the ventilator itself (in-line).

The Single Patient Use Circuit and Blue Adapter Assembly are patient circuit components that are used to connect the Volara System to the ventilator. They are sold separately from the system.