Summary: Baxter is recalling certain Volara System components due to a disconnection issue that may lead to insufficient ventilation. The FDA has classified this as a serious recall, advising customers to stop using the affected products immediately.

Key Takeaways:

  • The recall addresses the risk of disconnection, which could result in serious health consequences, including death.
  • Baxter has provided a recall plan, including instructions for stopping use, returning products, and receiving replacements.

Baxter is recalling certain Volara System 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.

Risk Associated with the Disconnection

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 use of affected products 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, but the FDA considers the recall to be the most serious kind, meaning that continued use of the device could result in injury or death.

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 the 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 on how to return the affected products.

Intended Use of the Volara System

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.

Photo via FDA