Table of contents
- Latest Medtronic Ventilator Recall Updates
- August 11, 2026: Additional Devices Added to the Recall
- June 12, 2025: MedTech Dive Reports on the Recall
- June 11, 2025: Medtronic Announces the Recall and FDA Publishes the Notice
- June 9, 2025: FDA Posts the Recall Database Entry
- May 21, 2025: Medtronic Starts the Recall
- Which Medtronic Ventilators Are Affected?
- Why Were the Medtronic Ventilators Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Legal Options
- Frequently Asked Questions
- Is There a Medtronic Ventilator Recall Lawsuit?
- What Should I Do If a Child Uses a Newport HT70 Ventilator?
- Who Can I Call for Technical Support on a Recalled Newport Ventilator?
- Is Medtronic Still Making Ventilators?
Medtronic recalled Newport HT70 and Newport HT70 Plus ventilators and certain related Newport service parts. Two capacitors may fail. The ventilator could then shut down during use. Its shutdown alarm may also fail to sound.
The FDA classified the action as a Class I recall, and the recall is open. Its notice cites 63 medical device reports, including two serious injuries and one death. Customers should stop using the affected devices.
No lawsuit, class action or MDL has been filed over these ventilators. Medtronic is not correcting them and will no longer service them. The notice tells customers to replace them with an alternate means of ventilation.
Latest Medtronic Ventilator Recall Updates
August 11, 2026: Additional Devices Added to the Recall
Medtronic mailed or emailed recall notices listing additional affected devices to customers, according to the FDA recall database entry for the Newport HT70 recall [1]. The entry now shows 5,394 units in commerce.
The entry lists the recall as open and classified. It notes that the manufacturer has initiated the recall and not all products have been corrected.
June 12, 2025: MedTech Dive Reports on the Recall
MedTech Dive reported on the recall the day after the FDA published Medtronic’s notice [2]. Its article said the FDA recall entry listed 4,842 affected ventilators in commerce worldwide at that time.
June 11, 2025: Medtronic Announces the Recall and FDA Publishes the Notice
Medtronic announced the voluntary recall of Newport HT70 and HT70 Plus ventilators. The FDA published the company notice, which says the FDA designated the action a Class I recall [3].
The notice also says Medtronic will keep working directly with the FDA and other regulatory bodies around the world on this voluntary recall.
June 9, 2025: FDA Posts the Recall Database Entry
The FDA posted Class 1 recall entry Z-1915-2025 for the Newport HT70 ventilator in its medical device recall database. The entry gives the FDA-determined cause as component design/selection.
The entry names Covidien, a Medtronic company, as the recalling firm. The posting came two days before Medtronic announced the recall publicly.
May 21, 2025: Medtronic Starts the Recall
Medtronic initiated the recall and mailed or emailed recall notices to customers. The notices asked customers to stop using the affected ventilators. The FDA recall database records May 21, 2025 as the date the firm initiated the recall.
Which Medtronic Ventilators Are Affected?
The recall covers the following Newport ventilators and service parts:
- Newport HT70 Ventilator, REF HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU
- Newport HT70 Plus Ventilator, REF HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WW-NA
- HT70-2 Control Board RoHS (REF GR-PCB3252A) and HT70-2 Control Board RoHS X1 (REF GR105796)
- HT70P Control Board RoHS X1 (REF GR105795)
- HT70 Conversion Kit (REF GRFSKHT70M-2)
The FDA recall entry identifies each affected device by REF or UDI-DI and serial number. The company notice has a table with the item name, manufacture date and use-by date. Check both against the label on your device.
Why Were the Medtronic Ventilators Recalled?
Medtronic’s announcement says the ventilators were recalled because two separate capacitors on the controller circuit board assembly may fail [4]. An investigation into customer complaints identified the capacitors.
The FDA notice says no instances of both capacitors failing on the same circuit board have occurred. It says they are not anticipated to occur.
If a ventilator fails and does not provide adequate ventilation, the patient may not be able to breathe on their own.
That may lead to low oxygen levels, high carbon dioxide levels and potentially severe consequences like brain injury or death. This is the company’s statement of potential harm. It is not a finding of cause in any case.
Reported Incidents, Injuries, or Illnesses
The FDA notice counts 63 medical device reports associated with the capacitor issue. They include two serious injuries and one death. The count is from the June 11, 2025 notice, which states no reporting cutoff date.
A report is not proof that the ventilator caused an injury or death. The notice presents the figures as reports tied to the issue.
HT70 and HT70 Plus ventilators are intended for home users, as well as for infant and pediatric patients. The notice says these patients may be at higher risks of injury or death due to unanticipated ventilator failures.
What Should Consumers Do?
Follow these steps if you or someone in your care uses an affected Newport ventilator:
- Stop using the affected ventilator and replace it with an alternate means of ventilation.
- Keep an alternate power source and means of ventilation on hand. A patient on a ventilator needs the constant attention of trained caregivers.
- If the patient is not responding to ventilation, take the patient off the ventilator. Connect an alternate method of ventilation and contact the physician.
- After the change, quarantine the affected ventilators and service parts and dispose of them. Patients are asked to return affected devices to their healthcare provider.
- Know that Medtronic is not correcting the devices and will no longer service them. Call Medtronic Customer Service at 800-962-9888 with questions.
- Report adverse events or product quality concerns to the FDA and Medtronic through the FDA’s MedWatch program. You can also call the FDA at (800) FDA-1088 [5].
Legal Options
A recall does not automatically mean that anyone is liable or entitled to anything. A free case review can look at whether a person harmed while using an affected ventilator may have a claim.
Keep the ventilator and its serial number and REF. Keep the recall letter and purchase or rental records. Keep photographs of the device and its alarm, medical records and messages with Medtronic or the care team.
Frequently Asked Questions
Is There a Medtronic Ventilator Recall Lawsuit?
There is a Medtronic ventilator recall, and it is an FDA Class I action. A recall is separate from a court case. Deadlines for legal claims come from state law and vary with where a person lives and when the injury and its cause were discovered.
What Should I Do If a Child Uses a Newport HT70 Ventilator?
If a child uses a Newport HT70 ventilator, the caregiver should follow the stop-use instruction in the notice. Infant and pediatric patients may be at higher risk of injury or death from unanticipated ventilator failure, so ask the child’s physician about an alternate means of ventilation.
Who Can I Call for Technical Support on a Recalled Newport Ventilator?
For technical support on a recalled Newport ventilator, call Medtronic Technical Support at 800-255-6774. Press option 1, then option 1 again. Medtronic Customer Service handles questions about the recall itself.
Is Medtronic Still Making Ventilators?
Medtronic is exiting ventilators. In February 2024 it announced its decision to exit its ventilator product lines, including the Newport ventilators. It is winding down the business over the coming years while honoring existing contracts.