FDA Class I Recall Medtronic Newport Ventilators After Death, Injuries

Medtronic has issued a voluntary recall of specific Newport HT70 and HT70 Plus ventilators and related service parts, classified as a Class I recall by the FDA, the most serious type indicating potential for severe health consequences or death. The recall was prompted by customer complaints revealing that two separate capacitors on the ventilators' controller printed circuit board assembly may fail, causing the ventilators to shut down during use or the shutdown alarm to fail, which risks respiratory failure and potentially fatal outcomes including brain injury. There have been 63 medical device reports linked to these issues, including two serious injuries and one death. Medtronic advises discontinuing clinical use of these devices and removing them from circulation, as the company will not correct the faults or continue servicing the affected ventilators. The Newport HT70 and HT70 Plus ventilators are used in home and pediatric settings, where patients may be at higher risk due to unanticipated failures. Medtronic, which announced plans to exit the ventilator market last year, continues to support customers during the wind-down of this business segment.