FDA Upgrades Medtronic Recall Of Newport Ventilators To Class I

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(RTTNews) - Medical devices maker Medtronic plc has urged customers to discontinue clinical use of the recently recalled certain Newport branded ventilators and certain related service parts after the U.S. Food and Drug Administration upgraded it to a Class I recall.

According to the FDA, a Class I recall is the most serious type of recall, a situation where the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Medtronic in May issued the recall notification related to specific Newport HT70 and HT70 Plus ventilators and certain related Newport service parts.

The impacted Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support. 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.

The recall was initiated after customer complaints, and the related probe identified two separate capacitors on one of the ventilator's controller Printed Circuit Board Assembly or PCBA. This, in case of failure, may result in the ventilator shutting down during use, or the shutdown alert alarm failing to sound effectively.

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 or MDRs associated with this issue, including two serious injuries and one death, the firm noted. The company added that no instances of both capacitors failing on the same PCBA board have occurred, nor are they anticipated to occur.

Medtronic said it is not correcting these issues on affected ventilators or service parts and will no longer service affected ventilators. Instead, the customers are asked to remove the affected devices from use and replace with an alternate means of ventilation.

The firm will continue working directly with the FDA and other regulatory bodies around the world on the recall.

Medtronic in February 2024 had announced its decision to exit its ventilator product lines, including the Newport ventilators. As they wind down the business over the coming years, the company said it will continue to serve the existing ventilator contracts.

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