The company first sent customers an urgent medical device recall letter related to its Life2000 ventilator on May 29. On June 26, the FDA listed the recall as Class I, the most serious kind, as device use can lead to serious injury or death. An FDA notice now highlights the need for device removal for the Life2000 ventilator.
Baxter recalled the ventilator due to the potential for failure of the battery charging dongle. This can prevent the system from charging or only allow for intermittent charging. Using affected products may cause serious adverse health consequences. That includes a drop in oxygen levels (desaturation episodes) if the ventilator stops running or only runs intermittently due to low battery. Desaturation episodes can range from mild to potentially life-threatening, and can even cause death in a critically ill patient.
The company reports one injury related to the recall and zero deaths to date.
Baxter instructed customers to make sure they have another method for providing ventilation or oxygen therapy. They should inspect the charger dongle and make sure the battery charges appropriately. Customers may continue use of the ventilator once they confirm that charging continues as expected and there is no damage. They can obtain a replacement ventilator from Baxter if they find damage on the dongle or if the system fails to charge as expected.
