In 2021, a unit of healthcare giant Johnson & Johnson announced it had added artificial intelligence to a medical device used to treat chronic sinusitis. Acclarent said the TruDi Navigation System would use machine-learning software to assist ear, nose and throat specialists during surgery.

The device had already been on the market for about three years.

Before AI was added, the US Food and Drug Administration had received unconfirmed reports of seven malfunctions and one patient injury.

After the AI update, the FDA received reports of at least 100 malfunctions and adverse events.

At least 10 patients were reportedly injured between late 2021 and November 2025.

Most reports alleged that the TruDi system incorrectly informed surgeons about the location of their instruments inside patients’ heads.

Reported injuries included cerebrospinal fluid leaks, punctures at the base of the skull, and strokes caused by damage to major arteries.

FDA device reports are not designed to determine causes, and it remains unclear what role AI may have played.

However, two stroke victims filed lawsuits in Texas alleging that the TruDi system’s AI contributed to their injuries. One lawsuit alleges the device was safer before artificial intelligence was integrated.

Johnson & Johnson referred questions to Integra LifeSciences, which acquired Acclarent and the TruDi system in 2024.

Integra said the reports indicate the device was used only during surgeries in which adverse events occurred, and there is no credible evidence linking the AI technology to the alleged injuries.

The TruDi system is not the only AI-enabled medical device under scrutiny.

The FDA authorises more than 1,300 AI-based medical devices.

Reports have also raised concerns about AI-assisted heart monitors and ultrasound devices.

A research letter published in JAMA Health Forum found that 60 FDA-authorised AI medical devices were linked to 182 recalls.

About 43% of those recalls occurred within a year of approval.

In two lawsuits, patients alleged they suffered strokes after carotid arteries were damaged during sinus procedures in which the TruDi system was used.

Acclarent has denied the allegations and says it did not manufacture the device, only distributed it.

Integra LifeSciences also denies any link between the AI technology and patient injuries.