In 2021, a division of Johnson & Johnson in the healthcare sector unveiled a significant advancement by integrating artificial intelligence into a medical tool used for treating chronic sinusitis. Acclarent introduced a machine-learning algorithm into its TruDi Navigation System to aid ear, nose, and throat specialists during surgeries.
Although the device had been available for approximately three years, the U.S. Food and Drug Administration (FDA) had only received unverified reports of seven malfunctions and one patient injury. However, since the incorporation of AI into the device, the FDA has received unconfirmed reports of over 100 malfunctions and adverse incidents.
Between late 2021 and November 2025, at least 10 individuals sustained injuries, with most cases involving errors wherein the TruDi Navigation System provided inaccurate information to surgeons regarding the location of their instruments during procedures inside patients’ heads.
Incidents included cerebrospinal fluid leakage from a patient’s nose, accidental puncturing of a patient’s skull, and two patients suffering strokes due to inadvertent injuries to major arteries. While the FDA reports may not provide conclusive causes of these incidents, two stroke victims filed lawsuits in Texas alleging that the AI technology in the TruDi system contributed to their injuries.
Johnson & Johnson redirected inquiries about the FDA reports to Integra LifeSciences, which acquired Acclarent and the TruDi Navigation System in 2024. Integra LifeSciences stated that the reports only indicated the presence of the TruDi system during surgeries where adverse events occurred and emphasized the lack of substantial evidence linking the system, AI technology, and alleged injuries.
The utilization of AI in the healthcare sector is rapidly evolving, promising transformative impacts. However, a review by Reuters highlighted safety concerns and legal issues as device manufacturers, tech companies, and software developers rush to deploy AI technologies in healthcare settings.
The FDA has authorized over 1,300 medical devices integrated with AI, a doubling from previous years. Apart from the TruDi system, several other AI-enhanced devices have faced scrutiny, including heart monitors and ultrasound tools. Research from esteemed universities revealed that FDA-authorized AI medical devices were associated with a significant number of product recalls, indicating potential risks.
The proliferation of AI-powered medical devices poses challenges for the FDA, as the agency faces difficulties in keeping up with the influx of new technologies following staff reductions. Additionally, the introduction of generative AI chatbots in healthcare settings raises concerns about patient self-diagnosis and adherence to professional medical advice.
AI technology’s integration into medicine has a long history, with the FDA authorizing the first AI-enhanced medical devices in 1995. The current AI applications often utilize machine learning and deep learning to enhance diagnostic accuracy and aid in surgical procedures, such as identifying tumors in radiology or guiding instruments during operations.
The incorporation of AI in medical devices has sparked controversies and legal disputes, exemplified by lawsuits involving the TruDi Navigation System. The evolving landscape of AI in healthcare necessitates stringent oversight and regulatory frameworks to ensure patient safety and efficacy in medical practice.
