Baxter’s Volara System Recall Gets Class I Treatment

In July, Baxter International announced the recall of certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. Today, that recall was identified as Class I, the most serious type, by the FDA.

The Volara system is intended for patients who are using a ventilator to help 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),” according to FDA.

MD+DI initially reported the recall on July 17, noting that the system, when used in conjunction with a ventilator and without a nebulizer connected to the blue ventilator adapter, is required to have the handset plug to help ensure proper operation and ventilator gas flow. The blue ventilator adapter was recalled after reports that the handset plug may disconnect from the nebulizer port on the blue ventilator adapter.

If disconnection were to occur and go unnoticed prior to or during therapy, the interruption or delay in care could result in “reduced ventilation and oxygenation due to the ventilator leaking gas flow from the nebulizer port on the blue ventilator adapter,” according to the company recall notice.

This could lead to brain injury, heart attack, respiratory failure, and death. Currently, there have been no reported injuries or deaths related to the issue.

FDA is doubling down on Baxter’s recommendation to stop using affected single-patient use circuits (unique device identifier: M08473, M08474) and blue ventilator adapters (M07937). However, the agency also noted that if a patient does not have another therapy option, they may continue to use it with caution. Patients are being instructed to visually inspect the nebulizer port prior to therapy and check for any ventilator gas flow leaks for the duration of therapy.