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As the integration of artificial intelligence (AI) into medical devices accelerates, alarming reports have emerged regarding the technology’s reliability in surgical settings. The U.S. Food and Drug Administration (FDA) now oversees a staggering 1,357 AI-enhanced medical devices—double the number approved just a year ago—but critics argue the agency is ill-equipped to manage the growing tide of potential risks that accompany this technological revolution.
A Surge in AI-Enhanced Devices
In 2021, Johnson & Johnson’s subsidiary Acclarent heralded a breakthrough in surgical technology with the introduction of AI into its TruDi Navigation System, designed to assist in sinus surgeries. However, this advancement has not been without complications. Initial reports indicated only a handful of device malfunctions, but post-AI integration, the FDA has documented at least 100 incidents of malfunction and adverse outcomes, including significant patient injuries.
From late 2021 to November 2025, ten individuals suffered injuries due to the TruDi system, which allegedly misled surgeons about the exact location of their instruments during critical procedures. In one case, a cerebrospinal fluid leak occurred; in another, a surgeon mistakenly punctured a patient’s skull, resulting in strokes for two individuals when major arteries were inadvertently damaged.
The Growing Concerns and Legal Wranglings
The FDA’s reports, while troubling, may not fully encapsulate the underlying issues as they often lack comprehensive detail. The agency has faced criticism for its inability to ascertain the exact role AI has played in these adverse events. Two stroke victims have since filed lawsuits in Texas, claiming that the integration of AI made the TruDi system less safe than its predecessor. One suit argues, “the product was arguably safer before integrating changes in the software to incorporate artificial intelligence than after.”
Acclarent, now owned by Integra LifeSciences, has responded to these claims by asserting that the reports indicate nothing more than that the TruDi system was operational during an adverse event, lacking proven causal connections to any injuries. Nevertheless, the growing incidence of reports—many involving other AI-enhanced devices like heart monitors and ultrasound machines—has raised significant concerns among healthcare professionals and regulators.
FDA Struggles Amidst the AI Surge
The rapid expansion of AI in medical devices has presented a formidable challenge for the FDA, as the agency grapples with a shortage of staff and expertise. Interviews with former FDA scientists reveal that the agency is currently struggling to keep pace with the influx of AI applications. This has raised alarm over the safety and effectiveness of these technologies, as many new devices bypass rigorous clinical testing processes that are typically required for pharmaceuticals.
Research conducted by Johns Hopkins, Georgetown, and Yale universities recently highlighted that 60 FDA-approved medical devices employing AI have been linked to 182 product recalls, with nearly half occurring within a year of market introduction. This recall rate is significantly higher than the average for devices authorised under similar FDA regulations.
AI in the Operating Room: A Double-Edged Sword
As AI technology continues to evolve, its potential benefits in healthcare are overshadowed by emerging risks. While proponents argue that AI can enhance surgical precision, improve diagnostic accuracy, and drive medical innovation, the reality is that many of these devices are being rolled out without comprehensive safety evaluations. Generative AI chatbots and other tools are now commonplace in healthcare settings, but they too present new challenges, with patients increasingly relying on these technologies for self-diagnosis and medical advice.
Acclarent’s TruDi system is not an isolated incident. Reports persist of AI systems misidentifying critical elements, including fetal body parts in prenatal ultrasounds, which raises further questions about the reliability of AI in sensitive medical contexts. For instance, one report stated that the Sonio Detect software misidentified fetal structures, although Samsung Medison, the manufacturer, asserted these issues did not indicate any safety concerns.
Why it Matters
The integration of AI into surgical practices is poised to redefine the landscape of healthcare, but it carries with it a myriad of challenges that cannot be overlooked. With the FDA struggling to keep pace with technological advancements and a concerning rise in reports of adverse events related to AI devices, the safety of patients hangs in the balance. As the medical community pushes for innovation, it must also advocate for robust regulatory frameworks that ensure these cutting-edge technologies can be safely integrated into patient care. The stakes are high—when it comes to health, precision is not just a goal; it’s a necessity.
