Baxter issues urgent correction for Volara breathing device circuits due to leak risk

Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use.

The notice explains that the patient circuits can leak air and medication from the nebulizer cup during therapy, which may reduce oxygenation and make nebulization ineffective. The FDA classifies the correction as the most serious type because continued use without fixing the issue could cause serious injury or death.

Affected items include several Volara circuit kits identified by product codes. Baxter recommends inspecting the nebulizer cup for damage before each use, ensuring it is fully filled and securely locked, and replacing the circuit if any leakage is observed.

Customers were instructed on May 21 to follow these steps and to discontinue use of any leaking nebulizer. Home‑care patients should seek guidance if leakage persists or they are uncertain about the device’s condition.