US FDA Reports Flag Rise In Injuries Linked To AI-Enabled Medical Devices: Report

A medical device used to treat chronic sinusitis saw a sharp rise in reported malfunctions and patient injuries after artificial intelligence was added to its software, raising broader concerns about the rapid rollout of AI in healthcare, Reuters reports.

In 2021, a Johnson & Johnson unit, Acclarent, introduced machine-learning software into its TruDi Navigation System, calling it a major advance in sinus surgery. Before the AI upgrade, the US Food and Drug Administration (FDA) had received unconfirmed reports of seven malfunctions and one patient injury linked to the device. Since then, the FDA has received reports of at least 100 malfunctions and adverse events, Reuters reports.

At least 10 patients were injured between late 2021 and November

2025, according to FDA reports reviewed by Reuters. The incidents allegedly involved the system misinforming surgeons about the position of surgical instruments inside patients’ heads.

Reported injuries included cerebrospinal fluid leakage, skull punctures and strokes caused by damaged arteries. Reuters reports that two stroke victims have filed lawsuits in Texas alleging that the AI-enabled TruDi system contributed to their injuries, though the news agency could not independently verify the claims.

FDA reports are not intended to establish causation, and it remains unclear what role AI played in the incidents, Reuters reports. Johnson & Johnson referred questions to Integra LifeSciences, which acquired Acclarent in 2024. Integra said the reports only indicate that TruDi was in use during surgeries where adverse events occurred and that there is “no credible evidence” linking the AI technology to patient injuries.

The scrutiny comes as AI adoption accelerates across healthcare. According to Reuters, at least 1,357 AI-enabled medical devices have now been authorised by the FDA, double the number approved through 2022. FDA records show reports involving dozens of AI-assisted devices, including heart monitors and ultrasound systems, with some alleging misidentification of body parts or missed abnormalities.

Researchers from Johns Hopkins, Georgetown and Yale universities found that 60 FDA-authorised AI devices were linked to 182 recalls, with 43% occurring within a year of approval, Reuters reports. The recall rate was roughly double that of comparable non-AI devices.

FDA officials and former staff told Reuters the agency is struggling to keep pace with the surge in AI-powered devices after losing specialised staff. While the FDA and the US Department of Health and Human Services say patient safety remains the top priority, former reviewers warned that reduced resources could increase the risk of oversight failures.

As AI becomes more deeply embedded in medical devices and clinical decision-making, experts cited by Reuters caution that existing regulatory frameworks may not be sufficient to ensure safety, placing greater reliance on manufacturers at a time when the technology is evolving rapidly.