Defect in Medtronic Ventilator Could Cause Serious Issues or Even Death
About the Covidien Ventilator Recall
According to MassDevice, a significant error in the device can cause the air delivery volume to be lower than what is needed.
The hazard comes from a software error that could happen when the ventilator is in the neonatal volume control plus mode with active humidification. The defect can result in patients having to be removed from the machine due to lack of oxygen.
As dictated by the FDA, the recall is classified a Class I recall. This is the most serious type of recall and said “there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.”
Description of the Recalled Ventilators
The recall affects 657 units manufactured and sold between March 2014 and June 2015.
According to the FDA, units with the following product codes are under the recall:
The manufacturer, Medtronic, alerted consumers with the product of the issue in July.
This is the second time in a year that the FDA has issued a Class I recall for the same units due to programming deficiencies.