AI-Powered Surgical Devices Linked to Over 1,400 Safety Reports Since 2021

U.S. regulators have received more than 1,400 reports since 2021 involving devices on the FDA's AI list, including allegations of botched surgeries and software that misidentified body parts. The FDA has authorized at least 1,357 AI-integrated medical devices, double the number it had allowed through 2022.

The TruDi Navigation System, manufactured by Acclarent, a subsidiary of Integra LifeSciences under the Johnson & Johnson umbrella, has been used in operating rooms for the past three years after gaining FDA approval. AI is embedded in the tool's navigation system designed to guide surgeons operating inside a patient's head. The tool didn't previously use AI, but was updated in 2021 to include machine-learning algorithms to assist ear, nose and throat specialists in surgeries.

Before AI was added, the FDA had received seven malfunction reports and one injury. After the update, the agency logged at least 100 reports of malfunctions, including 10 injuries, through late 2025. Many of the reports describe the system allegedly misinforming surgeons about where their instruments were while operating near critical bodily structures like the carotid artery and the base of the skull.

Two cases in Texas that are now in court involved patients who suffered strokes after arteries were allegedly damaged during routine sinus procedures. One woman required part of her skull to be removed to relieve brain swelling. The lawsuits claim that the AI component made the device less reliable. In one case, the suit alleges that the company "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."

Integra LifeSciences responded saying there is "no credible evidence" linking the AI tech to the injuries. The companies argue that the FDA reports don't prove fault. FDA reports on malfunctioning devices aren't intended to determine causes of medical mishaps, so it's not clear what role AI may have played in these events.

Other AI-assisted devices have also faced allegations of performance issues. A prenatal ultrasound tool called Sonio Detect has been accused of using a faulty algorithm that misidentifies fetal structures and body parts. Heart monitors made by Medtronic have faced allegations that the monitors failed to recognize abnormal rhythms or pauses in patients.

A joint academic review by Johns Hopkins University, Georgetown, and Yale found that 60 AI-authorized devices were tied to a total of 182 recalls, with nearly half occurring within a year of approval. Research published in JAMA Health Forum found that at least 43% of these recalls occurred within the first 12 months of the device's FDA approval, suggesting that the FDA's approval process may overlook early performance failures of AI technologies.

AI-enabled medical devices can pose safety risks, especially because they are not required to undergo clinical trials in patients. Many of these AI surgical tools address the area of vision enhancement. Traditional laparoscopic surgery presents surgeons with significant challenges: smoke obscures the surgical field, two-dimensional images make depth perception difficult and critical anatomical structures can be hard to distinguish. AI surgical tools can eliminate these obstacles and provide surgeons with crystal-clear views of the operative field.

A spokesperson for the U.S. Department of Health and Human Services said patient safety remains the top priority and the agency will continue to learn more about AI and digital health. The FDA expanded its roster of AI specialists, though former employees said staffing cuts increased workloads.