Early Alert: Positive Pressure Breathing Device Issue from Baxter

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Baxter has issued an Urgent Medical Device Correction notice to affected customers recommending all Volara System patient circuits be corrected prior to continued use. 

Affected devices:

What to Do

Carefully inspect the nebulizer cup for damage before each use. Ensure the nebulizer cup is full and securely locked during assembly. If leakage is observed, discontinue the use of that nebulizer and replace the patient circuit.

On May 21, Baxter sent all affected customers a letter recommending the following actions:

• Before each use, carefully inspect the nebulizer cup for damage and ensure it is fully and securely locked during assembly, following the instructions enclosed in Baxter’s Urgent Medical Device Correction notice. 
• If leakage is observed during therapy, discontinue the use of that nebulizer and replace the patient circuit. 
• Home Care Patients: If leakage persists or you are unsure whether to continue therapy, contact your healthcare provider or care team for guidance
• Nebulizer cups with patient circuits are routinely replaced as part of normal therapy usage. Additional patient circuits can be provided through standard distribution.
• If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 
• If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this urgent medical device correction. Please continue distributing this communication to all new customers until the IFU updates are complete. Baxter will advise when the new IFU is released.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Baxter stated that Volara System single-patient use circuits may experience air and medication leakage from the nebulizer cup during therapy. The leakage can lead to patient desaturation and ineffective nebulization, impacting the delivery of prescribed therapy. The issue has been associated with improper locking of the nebulizer after medication is added to the cup.

If the nebulizer cup is damaged or is not properly engaged during assembly, this issue could lead to medication leakage and ineffective delivery of therapy. If less medication than intended reaches the lungs, the mechanical benefits may still occur; however, the pharmacologic benefit may be reduced or lost. This may lead to serious or critical adverse health consequences such as increased airway inflammation and mucus retention (which may lead to mucus plugging and/or infection), prolonged coughing, worsening shortness of breath, and/or reduced oxygenation. Leaks in the breathing circuit could lead to hypoxia and hypoventilation as the patient receives lower tidal volume than prescribed and particularly concerning for pediatric patients receiving therapy at home.

As of May 21, Baxter has reported one serious injury and no deaths associated with this issue.

Device Use

The Volara System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with an oxygen supply. Volara System is intended to deliver therapy to adults and children over the age of two in the acute care setting, and to adults and children over the age of five in the home care setting.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter at 1-800-426-4224 and select option 2. For clinical assistance with your Volara therapy, please contact Baxter’s Clinical Support team at 1-800-397-9071.

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 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.