This month, the manufacturer of medical ventilators for critically ill babies has issued a nationwide recall of thousands of Life Pulse High-Frequency Ventilator Patient Circuits. The high-frequency ventilator is used to treat infants in intensive-care units. The patient circuits, which are made of disposable tubing, provide a conduit for humidification, warming and temperature monitoring of pressurized gas.

Bunnell, Inc., the manufacturer, issued the Class I medical device recall notification Dec. 12 after receiving customer complaints that the device has heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge. Melted insulation also can cause a fire in an oxygen-rich environment of an intensive-care unit and did so during laboratory testing, the manufacturer said. There have been 12 reported failures out of 5,743 Patient Circuits that have been distributed—a failure rate of less than 1 percent.

In the recall notice, Bunnell warned doctors and health-care providers that a Patient Circuit failure could result in patient injury or death. The manufacturer said it had not received any reports to date of patient injury or death. A class I recall is the FDA’s highest classification of recall, because of the potential risk of serious injury or death.

The company is recalling all patient circuits manufactured since March 2012.

Bunnell said it does not have patient circuits available to replace the recalled circuits at this time, but wanted to alert health-care providers of the potential risks of the device. The company is working with the U.S. Food and Drug Administration to resolve the issue.

No infant fighting for its life in an intensive care unit should be exposed to an unsafe ventilator. The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by defective medical devices.