FDA Says Covidien’s PB980 Ventilator Recall is Class 1

The FDA has issued on update on Covidien’s Nov. 4 recall of its Puritan Bennett 980 (PB980) ventilator series system, deeming it a Class 1 recall because of the risk of serious injury or death.

The recall by the Medtronic subsidiary was prompted by incorrect assembly of a component on the printed circuit board, which may cause the device to become inoperable during use.

Users were advised to remove the affected ventilators from service and quarantine them pending a replacement of the printed circuit board assembly by the company.