Update on Covidien’s Ventilator Recall Due to Manufacturing Error

The FDA has issued on update on Covidien’s recall of its Puritan Bennett 980 Series ventilator, deeming it a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is a capacitor assembly error that may cause the ventilator to stop working as intended. If this occurs, the FDA said, it could result in the loss of ventilation and serious adverse events, such as an increase of carbon dioxide in the blood, an abnormally low amount of oxygen in the blood, neurological injury or death.

The 135 affected ventilators were distributed by Covidien, a Medtronic subsidiary, from Feb. 23, 2017, to April 4, 2020. There have been six complaints and one death reported, the agency said.