Bunnell Incorporated is initiating a voluntary, nationwide recall of its Life Pulse high-frequency ventilator patient circuits, according to a notification published by the FDA.

The product contains heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge. There have been 12 reported failures out of 5,771 patient circuits distributed. There have been no reports of patient injury or death. However, Bunnell wants clinicians to be aware of the potential that a circuit failure could result in patient injury or death.

Bunnell is working with the US Food and Drug Administration to resolve this issue.

The company will notify customers via certified mail and will post the recall notification and other important information on its site. Customers can e-mail Bunnell at [email protected] or they can call 800-800-4358, extension 6, between 8 am and 4 pm (Mountain), Monday through Friday.