Medtronic Newport Ventilator Recall Class 1

FDA says the Medtronic 5/2025 recall of specific Newport HT70 and HT70 Plus ventilators and certain related Newport service parts is Class 1. An agency notice says the company was advising customers to discontinue clinical use of the affected devices.

Investigation into customer complaints identified two separate capacitors on one of the ventilators’ controller printed circuit board assembly (PCBA) that could fail, the notice says. In that event, it could result in the ventilator shutting down during use or the shutdown alert alarm failing to sound effectively.

“No instances of both capacitors failing on the same PCBA board have occurred, nor are they anticipated to occur,” the company said.

Medtronic told customers to remove the affected devices from use and replace them with an alternate means of ventilation. It said it is not correcting the issues on affected ventilators or service parts and will no longer service affected ventilators identified in the recall.