> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Early Alert on Baxter Volara Breathing Device Circuits
- URL: https://www.fdaweb.com/early-alert-on-baxter-volara-breathing-device-circuits/
- Published: 2026-06-11T12:00:00.000Z
- Updated: 2026-09-14T13:41:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161299

FDA has issued an [early alert](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-positive-pressure-breathing-device-issue-baxter?ref=fdaweb.com) regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara System, a positive pressure therapy device used to mobilize lung secretions and deliver aerosolized medications.

According to the agency, Baxter has initiated an urgent medical device correction involving several single-patient-use Volara System circuit kits after identifying a risk of air and medication leakage from the device's nebulizer cup during therapy.

The issue can occur if the nebulizer cup is damaged or not fully locked into place after medication is added, FDA says. Leakage may result in reduced delivery of prescribed medication and diminished respiratory therapy effectiveness, potentially leading to serious health consequences, including worsening shortness of breath, increased airway inflammation, mucus retention, infection, prolonged coughing, and reduced oxygenation.

The FDA says leaks in the breathing circuit may also cause hypoxia and hypoventilation by reducing the tidal volume delivered to patients. Pediatric patients receiving therapy in the home setting may face heightened risk.

The Volara System is indicated for secretion mobilization, lung expansion therapy, treatment and prevention of pulmonary atelectasis, and supplemental oxygen delivery when connected to an oxygen source.