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 v…