Class I designations, the FDA’s most serious classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
Medtronic’s North Haven, Connecticut-based Covidien unit initiated the recall for the Puritan Bennett 980 Series Ventilator (980A1ENNISB) on Nov. 4, 2021. There were a total of 278 devices in commerce.
The reason for the recall was a manufacturing assembly error in which a capacitor within the ventilator was assembled incorrectly, which could cause the device to become inoperable during use, according to an FDA database.
In response to the issue, the firm began to notify customers of the device defect on Nov. 4. Medtronic said users should remove the affected ventilators from clinical service and quarantine the affected ventilators until a Medtronic technical service engineer inspects and replaces the affected printed circuit board assemblies.
There have been previous recalls and updates related to the Puritan Bennett 980 Series system, including a 2018 software update to the external USB drive performance and its impact on graphical user interface (GUI) functionality. The update also covered the labeling displayed on the GUI during ventilator use and included product enhancements.
In 2015, the system had a Class I recall because as a result of an error that can cause air delivery volume to be lower than necessary.