The FDA has labeled the recall as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recall is over a software error that can occur when the ventilator is in the neonatal volume control plus mode with active humidification which causes the volume of air being delivered to be lower than that programmed.
The lack of appropriate air volume may require patients to be removed from the ventilator, as being left on the malfunctioning unit may cause a lack of oxygen which can result in injury or death, according to the FDA filing.
A total of 657 units in the U.S., manufactured and distributed between March 2014 and June 2015, are affected by the recall. The FDA indicated that units with product codes 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS are affected by the recall.
Medtronic began notifying customers with the product of the issue on July 17, advising them to actively monitor patients on the ventilator using the neonatal mode and transfer stable patients away from the units if necessary.
In November last year the FDA issued a similar Class I recall on the same units over a programming glitch in models of the ventilators using the 2.8 software, which may stop working after the air and oxygen supplies are disconnected and then reconnected.
The original recall came just 8 months after Covidien won FDA clearance for the ventilator in the U.S. market.