Medtronic Ventilators Recalled Following FDA Class I Designation

According to a June 11 press release, Medtronic has issued a voluntary global recall of specific Newport HT70 and HT70 Plus ventilators and related service parts due to a potential risk of device shutdown and alarm failure. The FDA has classified the recall as Class I—the most serious type—due to the possibility of injury or death if the ventilators fail during use.

The recall stems from issues with two capacitors on the ventilator’s control circuit board, which could cause the device to stop functioning or fail to alert users of a shutdown. Although both capacitors have not failed simultaneously in any reported cases, 63 adverse event reports have been filed, including two serious injuries and one death.

Medtronic advises customers to immediately discontinue use of the affected devices and switch to alternative ventilation methods. The company will not repair or service the impacted units. The recall affects devices used in homes and clinical settings, including care for infants and pediatric patients.