FDA Class I Recall: Puritan Bennett 980 Series Ventilator by Covidien

Jan. 6, 2022

The U.S. Food & Drug Administration (FDA) announced that Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended. This is a Class I recall.

Ventilators are machines that provide respiratory support by acting as bellows to move air in and out of your lungs. If the ventilator stops working, it could result in the loss of ventilation and serious adverse events such as hypercarbia (an increase of carbon dioxide in the blood), hypoxemia (an abnormally low amount of oxygen in the bloodstream), neurological injury or death.

There have been six complaints and one death regarding this device issue. There have been no reported injuries.

FDA release