FDA Struggles to Regulate AI Medical Devices as Injuries Mount
Artificial intelligence integrated into surgical devices is causing significant patient harm, including misidentification of body parts and severe injuries, according to recent reports. The U.S. Food and Drug Administration (FDA) has now authorized at least 1,357 medical devices using AI, which represents double the number permitted through 2022. This rapid expansion is occurring as the agency faces challenges in maintaining adequate oversight.
Chronic Sinusitis Device Linked to Multiple Injuries
In 2021, healthcare giant Johnson & Johnson's unit Acclarent announced a major advancement by adding artificial intelligence to its TruDi Navigation System, a device used to treat chronic sinusitis. Prior to the AI integration, the FDA had received unconfirmed reports of seven device malfunctions and one patient injury. Since the AI was incorporated, the agency has received at least 100 reports of malfunctions and adverse events.
Between late 2021 and November 2025, at least ten people were injured according to these reports. Most incidents allegedly involved errors where the TruDi system provided incorrect information to surgeons about instrument locations during operations inside patients' heads. Specific cases include cerebrospinal fluid leaking from a patient's nose, a surgeon accidentally puncturing the base of a patient's skull, and two patients suffering strokes after major arteries were injured.
Legal Actions and Manufacturer Responses
Two stroke victims have filed lawsuits in Texas alleging that the TruDi system's AI contributed to their injuries. One lawsuit claims "the product was arguably safer before integrating changes in the software to incorporate artificial intelligence than after the software modifications were implemented." Johnson & Johnson referred questions to Integra LifeSciences, which purchased Acclarent and the TruDi system in 2024.
Integra LifeSciences stated that the FDA reports "do nothing more than indicate that a TruDi system was in use in a surgery where an adverse event took place" and added that "there is no credible evidence to show any causal connection between the TruDi Navigation System, AI technology, and any alleged injuries."
Broader Pattern of AI Device Problems
The TruDi system is not alone in facing scrutiny. The FDA has received reports involving dozens of other AI-enhanced devices, including a heart monitor that allegedly overlooked abnormal heartbeats and an ultrasound device that reportedly misidentified fetal body parts. Researchers from Johns Hopkins, Georgetown, and Yale universities recently found that 60 FDA-authorized medical devices using AI were linked to 182 product recalls.
Their review, published in the JAMA Health Forum in August, showed that 43% of recalls occurred less than a year after device authorization, which is approximately twice the recall rate of all devices authorized under similar FDA rules.
FDA Capacity Challenges
Five current and former FDA scientists told Reuters that the agency is struggling to keep pace with the flood of AI-enhanced medical devices seeking approval after losing key staff. The Division of Imaging, Diagnostics and Software Reliability (DIDSR), which became the agency's key resource for assessing AI safety in medicine, grew to about 40 people early last year but has since been reduced through layoffs and departures.
Andrew Nixon, spokesperson for the U.S. Department of Health and Human Services, which includes the FDA, stated that "patient safety is the FDA's highest priority" and that the agency continues to recruit and develop talent with expertise in digital health and artificial intelligence. However, former employees report that workload has nearly doubled for some device reviewers since the cuts.
Specific Incident Details
In June 2022, surgeon Marc Dean used the TruDi Navigation System during a sinuplasty procedure on patient Erin Ralph in Fort Worth, Texas. According to Ralph's lawsuit, the system "misled and misdirected" Dean, resulting in injury to a carotid artery that supplies blood to the brain, face, and neck. Ralph suffered a stroke after leaving the hospital and required five days in intensive care, with a section of her skull removed to accommodate brain swelling.
In May 2023, during another sinuplasty operation, patient Donna Fernihough's carotid artery allegedly "blew" while Dean was using the TruDi system, causing blood to spray throughout the operating room. Fernihough also suffered a stroke the day of the surgery and has filed a lawsuit alleging that Acclarent "knew or should have known that the purported artificial intelligence caused or exacerbated the tendency of the integrated navigation system product to be inconsistent, inaccurate, and unreliable."
Additional Device Concerns
Reuters found that at least 1,401 reports filed to the FDA between 2021 and October 2025 concern medical devices on the FDA's list of 1,357 products that use AI. Of those reports, at least 115 mention problems with software, algorithms, or programming. One June 2025 report alleged that AI software called Sonio Detect, used for prenatal ultrasounds, was misidentifying fetal body parts.
At least 16 reports claimed that AI-assisted heart monitors made by Medtronic failed to recognize abnormal rhythms or pauses. Medtronic told Reuters that it reviewed all 16 episodes and concluded its device only missed one abnormal heart-rhythm event, adding that "none of these reports resulted in patient harm."
Regulatory Framework Limitations
Dr. Alexander Everhart, an instructor at Washington University's medical school and expert on medical device regulation, notes that most AI-enabled devices coming to market aren't required to be tested on patients under current FDA rules. Instead, manufacturers can satisfy requirements by citing previously authorized devices that had no AI-related capabilities.
"I think the FDA's traditional approach to regulating medical devices is not up to the task of ensuring AI-enabled technologies are safe and effective," Everhart told Reuters. "We're relying on manufacturers to do a good job at putting products out. I don't know what's in place at the FDA represents meaningful guardrails."
The Growing AI Healthcare Landscape
Artificial intelligence has been making its way into medicine for decades, with the FDA authorizing its first AI-enhanced medical devices in 1995. The technology is now used in various medical applications, from radiology to surgical devices, with proponents predicting it will help find cures for rare diseases, discover new drugs, and enhance surgeons' skills.
However, the rapid expansion of AI in healthcare, combined with regulatory challenges and reported safety incidents, highlights the need for more robust oversight as these technologies become increasingly integrated into patient care.
