Newport Ventilator Recall Issued by Medtronic Following One Patient Death: FDA

Manufacturer will be discontinuing use of certain ventilators due to unanticipated failures.

Federal health officials have announced a Class I recall impacting certain Medtronic Newport ventilators and service parts, due to a risk that a faulty capacitor on the controller’s circuit board may cause the device to shut down during use. 

The Newport ventilator recall was announced by the U.S. Food and Drug Administration (FDA) announced on June 11, following at least 63 reports involving problems with the medical device, including two serious injuries and one death linked to ventilator failures.

Medtronic Newport ventilators are designed to deliver continuous or intermittent breathing support for patients with respiratory infections, lung disease, brain injuries, strokes, drug overdoses or other conditions requiring invasive or noninvasive ventilation.

However, if the ventilator fails, patients may be left without sufficient breathing support, which can result in dangerously low oxygen levels, elevated carbon dioxide levels and life-threatening complications such as brain damage or death.

The recall affects Newport HT70 and HT70 Plus ventilators, which are used for infant, pediatric and adult patients in hospitals, long-term care facilities, emergency response settings, home care and during patient transport.

According to the notice, Medtronic identified a defect in one of the two capacitors on the ventilator’s controller circuit board, which may fail and cause the device to shut down during use or prevent the shutdown alarm from functioning properly.

Due to the risk of serious injury or death, the FDA has classified this as a Class I recall, the most severe type, indicating that continued use of the affected devices could result in life-threatening complications.

Healthcare providers are being instructed to stop using the recalled devices and replace them with an alternative means of ventilation. Medtronic is not correcting the issues on the affected ventilators or service parts, and will no longer service the affected ventilators identified in this notification. 

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

The FDA can be contacted at (800) FDA-1088 or online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. Medtronic Technical Support can be reached at 800-255-6774 (select option 1, then option 1).

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