The rapid integration of artificial intelligence into medical devices is facing scrutiny as reports of patient injuries and device malfunctions submitted to the U.S. Food and Drug Administration (FDA) have increased. A surgical navigation system used in sinus procedures has seen a significant spike in adverse event reports since incorporating AI, leading to multiple lawsuits from patients who suffered severe complications, including strokes.
Key Takeaways
- Reports of malfunctions and injuries for an AI-enhanced sinus surgery device have risen sharply since its software update in 2021.
- At least two patients have filed lawsuits alleging the device's AI contributed to strokes they suffered during routine procedures.
- The FDA has authorized over 1,300 medical devices with AI, but faces challenges in oversight due to staffing shortages and rapid technological advances.
- Concerns are growing over the regulatory process, as many AI-enabled devices are approved without new clinical trials on patients.
A Sharp Increase in Adverse Event Reports
In 2021, a new version of the TruDi Navigation System, a device used by surgeons during sinus procedures, was introduced with an artificial intelligence algorithm. The system, originally developed by Acclarent, a unit of Johnson & Johnson, is designed to help surgeons track the location of their instruments inside a patient's head.
Before the AI software was added, the FDA had received seven reports of device malfunctions and one patient injury report over approximately three years. Since the AI integration in late 2021, the agency has received unconfirmed reports of at least 100 malfunctions and adverse events related to the device through November 2025.
Among these are reports of at least 10 patient injuries. The incidents allegedly involved the system providing inaccurate information about the surgical instrument's position. Complications reported include a cerebrospinal fluid leak, a punctured skull base, and in two separate cases, strokes resulting from damage to a major artery.
The Role of Surgical Navigation
Surgical navigation systems act like a GPS for surgeons, using medical imaging to create a 3D map of the patient's anatomy. The AI in the TruDi system was designed to enhance this by calculating the shortest valid path for an instrument, providing real-time feedback to simplify the procedure.
Patients Allege Life-Altering Injuries
Two patients who underwent sinus surgery using the AI-enhanced TruDi system have filed lawsuits after suffering strokes. In June 2022, Erin Ralph, a mother of four, had a sinuplasty procedure in Fort Worth, Texas. Her lawsuit alleges the TruDi system “misled and misdirected” the surgeon, leading to an injury to her carotid artery.
After being discharged, Ralph suffered a stroke that required a five-day stay in intensive care and the removal of a section of her skull to accommodate brain swelling. “It is hard to walk without a brace and to get my left arm back working,” Ralph stated in a blog post about her recovery.
"The product was arguably safer before integrating changes in the software to incorporate artificial intelligence than after the software modifications were implemented," one of the lawsuits alleges.
Less than a year later, in May 2023, another patient, Donna Fernihough, suffered a stroke during a similar procedure performed by the same surgeon. Her lawsuit claims her carotid artery was damaged when the device allegedly malfunctioned, causing blood to spray across the operating room. The suit alleges that Acclarent rushed the technology to market with a goal of only 80% accuracy for some features, despite warnings about unresolved issues.
Integra LifeSciences, which acquired Acclarent and the TruDi system in 2024, stated that the reports do not establish a causal link between the device, its AI, and any alleged injuries. Acclarent has denied the allegations in both ongoing lawsuits.
Broader Concerns Across the Medical Field
The issues surrounding the TruDi system are not isolated. The FDA has now authorized at least 1,357 medical devices that use artificial intelligence, more than double the number it had approved through 2022. This rapid expansion has brought a new wave of challenges.
Other AI-enhanced devices have also been named in adverse event reports filed with the FDA:
- Prenatal Ultrasounds: An AI software called Sonio Detect was alleged in a June 2025 report to be “faulty and wrongly labels fetal structures.”
- Cardiac Monitors: At least 16 reports claimed that AI-assisted heart monitors from Medtronic failed to recognize abnormal heart rhythms.
Medtronic stated that after a review, its device missed only one event and that no patients were harmed. Samsung Medison, which owns Sonio Detect, said the report did not indicate a safety issue.
Recalls and AI Devices
A recent study by researchers from Johns Hopkins, Georgetown, and Yale universities found that 60 FDA-authorized medical devices using AI were connected to 182 product recalls. According to the research letter in JAMA Health Forum, 43% of these recalls happened less than one year after the devices received authorization.
Regulatory Oversight Under Strain
The surge in AI medical technology is straining the FDA's ability to provide effective oversight. According to current and former agency scientists, specialized teams responsible for reviewing AI devices have faced significant staff reductions. Early last year, a key unit that assesses AI safety, the Division of Imaging, Diagnostics and Software Reliability (DIDSR), lost about 15 of its 40 AI scientists.
This has reportedly nearly doubled the workload for some remaining reviewers, raising concerns that potential safety issues could be missed. “If you don’t have the resources, things are more likely to be missed,” a former device reviewer who left last year said.
Furthermore, the approval pathway for many new devices adds another layer of complexity. Most AI-enabled devices are not required to undergo new clinical trials on patients. Instead, manufacturers can gain authorization by demonstrating their product is “substantially equivalent” to a previously approved device, even one without AI capabilities.
Dr. Alexander Everhart, an expert on medical device regulation at Washington University’s medical school, suggests this long-standing practice introduces new risks with AI. “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,” he noted. As the industry continues its rapid push into AI, questions about how to balance innovation with patient safety remain at the forefront.