Elevated risk U.S. Food and Drug Administration

Newport™ HT70 and HT70 Plus ventilators and certain related service recall: Device & Drug Safety - Potential Defect

Recall published 1+ years ago

Device & Drug Safety - Potential Defect

Newport™ Medical devices — recalled medical devices
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Investigation into customer complaints identified two separate capacitors on one of the ventilator’s controller Printed Circuit Board Assembly (PCBA), that, in case of failure, may result in:

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
June 11, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Newport™
Product type
Medical devices

Products covered by this recall

Newport™ HT70 and HT70 Plus ventilators and certain related service parts

What the company announced

Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation

June 11, 2025 — In May 2025, Medtronic issued a voluntary recall notification to global customers related to specific Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall.

With this recall, Medtronic is advising discontinuation of clinical use of the affected devices. Investigation into customer complaints identified two separate capacitors on one of the ventilator’s controller Printed Circuit Board Assembly (PCBA), that, in case of failure, may result in:

The ventilator shutting down during use, or

The shutdown alert alarm failing to sound effectively.

The following table identifies the item name, manufacture date and use by date:

No instances of both capacitors failing on the same PCBA board have occurred, nor are they anticipated to occur.

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 (MDRs) 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.

Customer recommendations

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. Customers with questions should contact Medtronic Customer Service at 800-962-9888. Adverse events or product quality concerns with this product should be reported to the FDA and Medtronic:

Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail)

Call FDA at (800) FDA-1088 for MedWatch reports

Call Medtronic Technical Support at 800-255-6774 option 1, then option 1

Refer to the customer notification and the patient letter for additional information.

The Newport™ HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport™ HT70 family of ventilators is applicable for infant, pediatric, and adult patients greater than or equal to 5 kg (11 lbs) in hospital, sub-acute, emergency department, and home care environments as well as for transport and emergency response applications. The Newport™ HT70 operator’s manual can be found here .

Medtronic will continue working directly with the U.S. Food and Drug Administration (FDA) and other regulatory bodies around the world on this voluntary recall. In February 2024, Medtronic announced its decision to exit its ventilator product lines, including the Newport™ ventilators. The company continues to serve the needs of its customers and their patients worldwide, and honor existing ventilator contracts, as they wind down the business over the coming years.

Contacts:

Helga Radio

Public Relations

+1 (612) 270-4999

Ryan Weispfenning

Investor Relations

+1 (763) 505-4626

Identifying Affected Product (see image below)

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 5 kg
  • 11 lbs

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Newport™ — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medtronic — Consumers: Medtronic Customer Service, 800-962-9888 — Media: Helga Radio Public Relations, +1 (612) 270-4999

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Newport™ medical devices recalled?

Device & Drug Safety - Potential Defect Investigation into customer complaints identified two separate capacitors on one of the ventilator’s controller Printed Circuit Board Assembly (PCBA), that, in case of failure, may result in:

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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