FDA Classifies Medtronic Ventilator Recall as Class I After Reported Death

Medtronic has voluntarily recalled select Newport HT70 and HT70 Plus ventilators after reports of device shutdowns during use and alarm failures. The FDA classified the recall as Class I, its most serious level, following 63 medical device reports, including two injuries and one death. The company traced the issue to faulty capacitors on the ventilator’s controller circuit board.

Users are advised to remove affected units from circulation, as Medtronic will not repair or service them. The recall involves 4,842 devices, and comes over a year after Medtronic announced plans to exit the ventilator market due to unprofitability.

This follows a BMJ study highlighting delays in adverse event reporting, prompting the FDA to pilot a new communication process for high-risk recalls via its Center for Devices and Radiological Health (CDRH).

19-06-2025