Baxter Volara Single-Patient Use Circuits - Updated Instructions, Class I Recall

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This recall **involves updating instructions for using all devices, and does not involve removing them 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 without following the updated instructions.*

Affected Product

The FDA is aware that Baxter has issued an “Urgent Medical Device Correction letter notifying affected customers that all Volara system single-patient use circuits have updated use instructions. Affected devices:

• Product Description: Blue Ventilator Adaptor Module
  • This product is a single patient use circuit that is used as an accessory with Volara respiratory therapy systems
• Product Code: M07937
• Unique Device Identifier: 00887761984622

What to Do

Continue Volara therapy as prescribed. Monitor for signs of respiratory distress during Volara therapy when used in-line with a ventilator. If signs of respiratory distress occur, stop Volara therapy immediately and seek medical attention if the condition does not improve.

On February 18, Baxter sent all affected customers a letter recommending the following actions:

• Continue your Volara therapy as prescribed by your doctor.
• Refer to the IFU addendum provided directly by the firm for additional information related to use in the home care environment. The following warning was added for consideration related to this issue:
  • Warning - Patients that may have difficulty clearing secretions from the upper airway may require specialized therapy (for example, separate suction unit) in addition to Volara therapy. Please consult your physician to determine if additional therapy is appropriate
• Monitor for signs of respiratory distress (increased breathing rate; wheezing; bluish color around the mouth, on the lips, or on the fingernails; changes in alertness; or drop in oxygen saturation level, etc.) during Volara therapy when used in-line with your ventilator. If signs of respiratory distress occur, stop the Volara therapy immediately. If you experience signs of respiratory distress and do not see improvement, please seek medical attention.
• If you have questions or would like assistance with your Volara therapy in-line with a ventilator, please contact the Baxter Advanced Respiratory Clinical Support team at 800-397-9071, available 24 hours a day, 7 days a week. Clinical support can be provided via the phone, or Baxter can arrange for an in-person visit with a clinical patient trainer
• Baxter will contact you to arrange for a clinical patient trainer to conduct an in-home visit to review the IFU addendum. As part of the additional training, you will be asked to sign your confirmation of understanding of the training material and content of the IFU addendum. FDA believes that all consignees have now received the instructions for use addendum.

Reason for Correction

This is a correction to a previous recall, in which four patients did not receive the Instructions for Use Addendum.

Baxter stated that there is a risk for decrease in oxygen levels (oxygen desaturation) or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. These risks may occur when the Volara system is used in-line with a ventilator with the required Volara single-patient use circuit.

A home care patient or caregiver can set up the Volara device in-line with a home care ventilator for oscillation and lung expansion (OLE) therapy. The added flow and pressure from the Volara device may interfere with the accuracy of the therapy provided by the ventilator. This interference may result in oxygen desaturation or barotrauma.

The FDA has identified seven serious injuries and no deaths related to this issue between May 30, 2022, and March 24, 2026. In May 2022, Baxter Healthcare reported one serious injury and two deaths associated with this issue as part of their initial Urgent Medical Device Correction.

Device Use

The Volara system is a non-continuous ventilator (intermittent positive pressure breathing-IPPB) intended to intermittently deliver an aerosol to a patient’s lungs or to assist a patient’s breathing.

Contact Information

Customers in the U.S. with clinical questions about this issue should contact Baxter at 800-397-9071.

Additional FDA Resources

1. FDA Enforcement Report
2. CDRH Medical Device Recall Database
3. Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use | FDA [06/23/2022]
4. CDRH Medical Device Recall Database – Initial Recall
5. FDA Enforcement Report – Initial Recall

Unique Device Identifier (UDI)

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

• ## Content current as of:

04/09/2026

• Regulated Product(s)

  • Medical Devices