Class 1 Product Recall of Puritan Bennett 980 Series Ventilators by Covidien, LP
On November 4, 2021, Covidien, LP, (a division of Medtronics) issued a recall on Puritan Bennett 980 Series Ventilators. The FDA has labeled this as a Class 1 recall–the most serious type of recall. Anyone using one of these ventilators is advised by the FDA to take immediate action to replace it with another ventilator.
There are approximately 135 of these ventilators affected by the recall. They were distributed between February 23, 2017 and April 4, 2020.
The recall relates to a capacitor manufacturing assembly error that can cause the ventilator to become inoperable or stop working properly. This error can result in the loss of ventilation.
What Injuries Can the Recalled Ventilators Cause?
When the ventilators stop ventilating properly, the patient may suffer from the following:
- hypercarbia (increased carbon dioxide in the blood),
- hypoxemia (too little oxygen in the bloodstream),
- neurological injury, or;
There have been six complaints and one death regarding this device issue.
What is a Class 1 Product Recall?
A Class 1 Recall indicates that continued use of the product may result in serious injury or death.
What Should I Do If I Have One?
Medtronics has sent an urgent correct notice to known customers advising them of what actions to take. In short, they are asking customers to discontinue the use of the ventilator and find a replacement ventilator immediately, For more information please see the FDA recall notice.