In May 2025, Medtronic initiated a voluntary recall of specific Newport HT70 and HT70 Plus ventilators and certain related service parts. The U.S. Food and Drug Administration (FDA) has classified this action as a Class I recall, indicating the potential for serious adverse health consequences.
Medtronic's investigation into customer complaints revealed issues with two capacitors on the ventilator’s controller Printed Circuit Board Assembly (PCBA). Failure of these components could lead to the ventilator shutting down during use or the shutdown alert alarm not sounding effectively. However, no instances of both capacitors failing simultaneously have been reported or are expected.
The malfunction of these devices can result in inadequate ventilation, posing significant risks such as low oxygen levels, high carbon dioxide levels, brain injury, or death. To date, there have been 63 medical device reports associated with this issue, including two serious injuries and one death. These ventilators are used by home users and infant and pediatric patients who may be more vulnerable to such failures.
Medtronic advises customers to discontinue use of the affected devices and replace them with alternative ventilation solutions. The company will not repair or service the affected ventilators or parts. Customers can contact Medtronic Customer Service at 800-962-9888 for assistance. Any adverse events or product quality concerns should be reported to both the FDA and Medtronic through their respective channels.
The Newport HT70 family is designed for continuous or intermittent positive pressure mechanical support across various patient groups and environments including hospitals, emergency departments, home care settings, transport, and emergency response situations.
Medtronic is collaborating with the FDA and other global regulatory bodies on this recall process. In February 2024, Medtronic announced its decision to exit its ventilator product lines but remains committed to fulfilling existing contracts as it phases out this segment over time.
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