The Newport HT70 and HT70 plus ventilators are designed to provide breathing support for patients in need of mechanical ventilation. The devices can be used with infant, pediatric or adult patients who weigh more than 11 pounds, and are used in hospitals, healthcare facilities, home care environments and can be used during transport and emergency response situations, according to the FDA.
The recall is due to software issues which may cause the ventilator to shut down unexpectedly without sounding an alarm. If the device shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences including brain damage or death, according to the federal watchdog.
A total of 7,576 devices in the US with product code 73-CBK are being recalled, manufactured between March 4, 2010 and Jan. 26, 2017 and distributed between March 4, 2010 and Feb. 2, 2017, according to the FDA notice
Medtronic issued an urgent field corrective action on April 3 instructing customers to pay constant attention to the devices, maintain alternate power sources and means of ventilation and have appropriate monitors to assure sufficient oxygenation.
The FDA said that Medtronic expects to issue a software update to resolve the issue some time this month.