Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Figure 1: Volara system blue ventilator adapter and handset plug

• 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. 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 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.

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. 

Contact Information

Customers in the U.S. with questions about this recall should contact Baxter Advanced Respiratory customer service at 800-426-4224. Select option 2 for Acute Care Customer Service or option 3 for Home Care Customer Service.

Additional FDA Resources

• Baxter Healthcare Corporation Recalls Volara System for Risk of Respiratory Distress in Ventilated Patients During Home Use [06/23/2022] 
• FDA’s Enforcement Reports:
  • Volara System, Single Patient Use Circuit
  • Volara System, Blue Ventilator Adapter
• Medical Device Recall Database entries:
  • Volara System Single Patient Use Circuit
  • Volara System, Blue Ventilator Adapter Module

Additional Company Resources

• Baxter Issues Urgent Medical Device Recall for Volara System Single-Patient Use Circuit [07/15/2024]
• Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment [June 1, 2022]

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.