Medtronic Issues Class I Recall of Newport HT70 and HT70 Plus Ventilators Following 1 Death and 2 Serious Injuries

The core reason for this recall is:There is a risk of two independent capacitors failing abnormally on the ventilator controller printed circuit board assembly (PCBA).AlthoughNo record of simultaneous failure of dual capacitors in the same deviceHowever, if any capacitor fails, it may lead to sudden shutdown during equipment operation or malfunction of the alarm system. This will directly cause interruption of patient ventilation, leading to critical conditions such as a sharp drop in blood oxygen saturation and carbon dioxide accumulation. In extreme cases, it may induce brain damage or even death.

As of now, Medtronic has received 63 reports of adverse events related to medical devices.Including 2 serious injury incidents and 1 death case.

In response to the aforementioned risks, Medtronic requiresCustomers should immediately stop using the affected devices and switch to alternative ventilation methods. Medtronic will not fix these issues and will no longer provide service for the affected ventilators identified in this notice.

It is worth noting thatThis recall is directly related to Medtronic's strategic adjustment announced in February 2024 – the company has decided to gradually exit the ventilator business line, including the complete cessation of production and sales of the Newport series products.

HoweverMedtronic Commitment, will continue to fulfill existing contract obligations during the business transition period and maintain coordinated responses with global regulatory agencies such as the FDA to ensure continuity of customer service.