Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.
Medtronic has issued a voluntary recall notice for specific Newport HT70 and HT70 Plus ventilators, as well as certain related Newport service parts, advising customers to discontinue clinical use of the affected devices.
According to the company, an investigation into customer complaints identified two separate capacitors on the ventilator’s controller printed circuit board assembly (PCBA) that could fail. If either component fails, it may result in the ventilator shutting down during use or in the shutdown alarm not sounding effectively.
No instances of both capacitors failing on the same PCBA board have occurred, nor are they anticipated to occur, according to a company release.
If a ventilator fails and does not provide adequate ventilation, the patient may not be able to breathe on their own, leading to low oxygen levels, high carbon dioxide levels, and potentially severe consequences like brain injury or death. There have been 63 medical device reports associated with this issue, including two serious injuries and one death.
HT70 and HT70 Plus ventilators are intended for use by home users, as well as for infant and pediatric patients who may be at higher risks of injury or death due to unanticipated ventilator failures.
Customers should remove the affected devices from use and replace with an alternate means of ventilation. Medtronic is not correcting these issues on affected ventilators or service parts and will no longer service affected ventilators identified in this notification.
The US Food and Drug Administration (FDA) designated this recall a Class I recall, the most serious type. Medtronic notes in a release that it will continue working with the FDA and other regulatory bodies on this recall.
In February 2024, Medtronic announced its decision to exit the ventilator business, including the Newport product line. The company says it will continue to fulfill existing contracts and work with regulators as it winds down operations.
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