Medtronic Recalls Life-Support Ventilators After Serious Injuries and a Death

In June 2025, Medtronic issued a Class I recall—the most serious type—on its Newport HT70 and HT70 Plus ventilators, after the devices were linked to two serious injuries and one death. This alarming recall affects thousands of devices used to provide critical breathing support to infants, children, and adults in hospitals and homes across the globe. At KBD Attorneys, we believe the public deserves to know the truth and understand their legal rights when medical devices fail.

Key takeaway: The recalled ventilators may shut down during use or fail to trigger an alert alarm, potentially resulting in respiratory failure, brain injury, or death.

Affected product: Newport HT70 and HT70 Plus ventilators, and select service parts.

A Faulty Life-Saving Device: What Went Wrong

According to MedTech Dive, the recall was prompted by 63 medical device reports involving Newport ventilators, including incidents of sudden device shutdown and failure to sound alarm alerts. The underlying issue? A defect tied to two capacitors on the ventilator’s circuit board, which can malfunction and shut down the device mid-use. If the alarm also fails, caregivers may not be alerted in time to intervene.

Although Medtronic claims both capacitors are unlikely to fail simultaneously, even a single failure can render the ventilator useless during operation—endangering the lives of vulnerable patients, especially infants and children who rely on uninterrupted, mechanical respiratory support.

Devices Still in Use After Exit Announcement

Compounding the concern is the fact that Medtronic had already announced its decision to exit the ventilator market in 2024, according to the FDA. Despite that, the company continued supplying and servicing the devices while winding down the business. Thousands of Newport HT70 and HT70 Plus ventilators remained in circulation—4,842 units globally.

Only after multiple injuries and a fatality did Medtronic issue its recall, advising all customers to stop using the affected devices immediately and find alternative means of ventilation.

The FDA’s Official Recall Classification and Warning

On June 11, 2025, the FDA shared Medtronic’s announcement on its website, officially designating the recall as Class I, reserved for defects that pose a risk of serious injury or death.

According to the FDA’s safety bulletin:

“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.”

The FDA emphasized that patients using these ventilators—particularly infants and pediatric users—face a heightened risk from any failure. The recall notice instructs customers to remove the devices from clinical use and replace them with an alternate ventilation solution. Medtronic will no longer correct or service the recalled units.

Medtronic’s Responsibility and the Human Cost

Medtronic, as a leading medical device manufacturer, has a responsibility to ensure that its life-sustaining products are safe, especially when used in high-risk populations. But in this case, the company delayed its recall while continuing to support these ventilators, even as complaints mounted. By its own admission, Medtronic began investigating the issue after receiving reports of device failures—but only issued a public warning in May 2025 and followed with the FDA Class I recall in June.

Medtronic has made it clear: it will not fix the affected ventilators. It will not issue a software or hardware update, and it will no longer service the faulty devices. This decision leaves patients and healthcare providers scrambling for replacements while dealing with the emotional and physical aftermath of failed ventilation—sometimes with fatal consequences.

Who Is at Risk?

The Newport HT70 family of ventilators was widely used in:

• Hospitals and emergency departments

• Home care settings

• Pediatric and neonatal care

• Transport and emergency response

The devices support patients weighing at least 5 kg (11 lbs), meaning that infants, young children, and adults with respiratory conditions may all be affected. Because these ventilators were also used in home settings, the margin for error was even narrower. When a ventilator fails in a hospital, a trained team may respond immediately—but in a home setting, that’s not always possible.

This recall is not just a technical failure—it’s a public health risk, especially for families relying on ventilators outside of a hospital.

KBD Attorneys: Fighting for Families Harmed by Defective Medical Devices

At KBD Attorneys, we are committed to holding powerful medical device manufacturers accountable when their products injure or kill consumers. Defective ventilators like the Medtronic Newport HT70 series can cause devastating harm—from permanent brain injuries caused by hypoxia to the death of a loved one whose life depended on uninterrupted ventilation.

If you or a loved one were using a Newport™ HT70 or HT70 Plus ventilator and experienced:

• Sudden device shutdown

• Failure to alert caregivers

• Respiratory failure or complications

• Brain injury or death

—you may be entitled to file a product liability claim against Medtronic.

Our attorneys have deep experience in medical device litigation, and we are currently investigating defective devices including the Medtronic Newport ventilator recall. We can help investigate your case, access critical documentation, and advocate for the justice and compensation your family deserves.

Protecting the Public Through Legal Action

Device manufacturers must put patient safety above profit, especially when their products sustain life. By issuing this recall only after serious injuries and a fatality occurred, Medtronic failed in that obligation.

At KBD Attorneys, we are not only representing injured patients and families in litigation—we’re helping raise public awareness and push for stronger FDA oversight and earlier interventions. We believe that transparency, accountability, and advocacy are the most powerful tools to prevent future tragedies.

What You Can Do Next

If you or someone in your family was using an affected Medtronic ventilator and experienced health complications or device failure, we encourage you to:

1. Discontinue use of the device immediately as instructed by Medtronic and the FDA.

2. Report the incident to the FDA’s MedWatch system here.

3. Contact KBD Attorneys for a free, confidential consultation.

We’re here to help you navigate this difficult time, ensure your voice is heard, and fight for meaningful accountability from those responsible.

Sources:

• MedTech Dive: Medtronic recalls ventilators linked to 2 serious injuries, 1 death

• U.S. Food & Drug Administration: Medtronic Announces Voluntary Recall of Select Newport™ HT70 and Newport™ HT70 Plus Ventilators