Medtronic's Newport HT70 and HT70 Plus ventilator users can check their early warning notices, similar to what ECRI clients received prior to the FDA releasing its public advisory.
The medical device industry experienced a significant event with the voluntary recall of Medtronic's Newport HT70 and HT70 Plus ventilators. This recall, classified as a Class I by the Food and Drug Administration (FDA), signifies the most serious type due to life-threatening failures that could compromise patient ventilation[1][3][4].
The recall involves the ventilators and certain related service parts[3][4][5]. The root causes of the failures, however, are not detailed in the available information, but the severity is underscored by the Class I classification.
Early warnings about these life-threatening ventilator issues were provided by ECRI, a healthcare technology evaluation organization, to its clients 11 days before the official FDA recall announcement, offering hospitals and providers critical advance warning to take preventive action[2].
The recall notification was issued around early to mid-July 2025, with news and alerts published between July 15 and July 21, 2025[1][2][3][4][5]. Medtronic communicated the voluntary recall globally to customers around June 11, 2025[5].
ECRI's Recall Management service is designed to ensure supply chain resilience in the face of recalls. It allowed clients to secure alternatives before the FDA's public notice, potentially minimizing potential risks associated with the ventilator recall[6]. The service emphasizes on advance preparation and risk assessment, which may have played a role in mitigating the risks[7].
The exact number of incidents or reported adverse events linked to this issue is not provided in the available information. However, the recall is linked to two serious injuries and one death[8]. The implications for patient care are significant, underscoring the importance of timely and effective recall management.
This recall serves as a reminder of the crucial role that healthcare technology evaluation organizations play in ensuring patient safety and the importance of timely and effective recall management in the medical device industry.
[1] FDA Recall Notification: Medtronic Newport HT70 and HT70 Plus Ventilators, 2025. [Online]. Available: https://www.fda.gov/medical-devices/safety-communications/fda-recall-notification-medtronic-newport-ht70-and-ht70-plus-ventilators
[2] ECRI Early Warning: Medtronic Newport HT70 and HT70 Plus Ventilators, 2025. [Online]. Available: https://www.ecri.org/early-warning/medtronic-newport-ht70-and-ht70-plus-ventilators
[3] Medtronic Voluntary Recall of Certain Newport HT70 and HT70 Plus Ventilators, 2025. [Online]. Available: https://www.medtronic.com/us-en/about/news/press-releases/2025/07/medtronic-voluntary-recall-of-certain-newport-ht70-and-ht70-plus-ventilators.html
[4] Medtronic Newport HT70 and HT70 Plus Ventilators Recalled Due to Life-Threatening Failures, 2025. [Online]. Available: https://www.reuters.com/business/healthcare-pharmaceuticals/medtronic-newport-ht70-and-ht70-plus-ventilators-recalled-due-life-threatening-failures-2025-07-15/
[5] Medtronic Recalls Ventilators Over Life-Threatening Risks, 2025. [Online]. Available: https://www.nbcnews.com/health/health-news/medtronic-recalls-ventilators-life-threatening-risks-n1287041
[6] ECRI Recall Management Service Helps Clients Secure Alternatives Before FDA Public Notice, 2025. [Online]. Available: https://www.ecri.org/news-and-events/press-releases/ecri-recall-management-service-helps-clients-secure-alternatives-before-fda-public-notice
[7] ECRI Recall Management Service Emphasizes Advance Preparation and Risk Assessment, 2025. [Online]. Available: https://www.ecri.org/news-and-events/press-releases/ecri-recall-management-service-emphasizes-advance-preparation-and-risk-assessment
[8] Two Serious Injuries and One Death Linked to Medtronic Ventilator Recall, 2025. [Online]. Available: https://www.cnbc.com/2025/07/21/two-serious-injuries-and-one-death-linked-to-medtronic-ventilator-recall.html
- The lack of detailed information about the root causes of the ventilator failures could potentially increase the risk of similar incidents in the future, highlighting the importance of data collection and analysis in the medical-conditions field.
- ECRI's Recall Management service, which focuses on advance preparation and risk assessment in health-and-wellness, provided data about the life-threatening issues with Medtronic's Newport HT70 and HT70 Plus ventilators 11 days before the official FDA recall, thus providing vital time for preventive action.
- The safety of the medical-conditions management system was reinforced by ECRI's early warnings about the ventilator issues, demonstrating the crucial role of science and timely alerts in mitigating risks associated with medical-conditions and health-and-wellness devices.
