In 2021, a unit of healthcare giant
Johnson & Johnson announced “a leap forward”: It had added
artificial intelligence to a medical device used to treat
chronic sinusitis, an inflammation of the sinuses. Acclarent
said the software for its TruDi Navigation System would now use
a machine-learning algorithm to assist ear, nose and throat
specialists in surgeries.
The device had already been on the market for about three
years. Until then, the U.S. Food and Drug Administration had
received unconfirmed reports of seven instances in which the
device malfunctioned and another report of a patient injury.
Since AI was added to the device, the FDA has received
unconfirmed reports of at least 100 malfunctions and adverse
At least 10 people were injured between late 2021 and
November 2025, according to the reports. Most allegedly involved
errors in which the TruDi Navigation System misinformed surgeons
about the location of their instruments while they were using
them inside patients’ heads during operations.
Cerebrospinal fluid reportedly leaked from one patient’s
nose. In another reported case, a surgeon mistakenly punctured
the base of a patient’s skull. In two other cases, patients each
allegedly suffered strokes after a major artery was accidentally
FDA device reports may be incomplete and aren’t intended to
determine causes of medical mishaps, so it’s not clear what role
AI may have played in these events. The two stroke victims each
filed a lawsuit in Texas alleging that the TruDi system’s AI
contributed to their injuries. “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 suits alleges.
Reuters could not independently verify the lawsuits’
allegations.
Asked about the FDA reports on the TruDi device, Johnson &
Johnson referred questions to Integra LifeSciences, which in
2024 purchased Acclarent and the TruDi Navigation System.
Integra LifeSciences said the reports “do nothing more than
indicate that a TruDi system was in use in a surgery where an
adverse event took place.” It added that “there is no credible
evidence to show any causal connection between the TruDi
Navigation System, AI technology, and any alleged injuries.”
Insight into the incidents comes as AI is beginning to
transform the world of health care. Proponents predict the new
technology will help find cures for rare diseases, discover new
drugs, enhance surgeons’ skill and empower patients. But a
Reuters review of safety and legal records, as well as
interviews with doctors, nurses, scientists and regulators,
documents some of the hazards of AI in medicine as device
makers, tech giants and software developers race to roll it out.
At least 1,357 medical devices using AI are now authorized
by the FDA – double the number it had allowed through 2022. The
TruDi system isn’t the only one to come under question: The FDA
has received reports involving dozens of other AI-enhanced
devices, including a heart monitor said to have overlooked
abnormal heartbeats and an ultrasound device that allegedly
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, according
to a research letter published in the JAMA Health Forum in
August. Their review showed that 43% of the recalls occurred
less than a year after the devices were greenlighted. That’s
about twice the recall rate of all devices authorized under
similar FDA rules, the review noted.
FDA STRUGGLING TO KEEP PACE
The AI boom poses a problem for the FDA, five current and
former agency scientists told Reuters: The agency is struggling
to keep pace with the flood of AI-enhanced medical devices
seeking approval after losing key staff. A spokesperson for the
U.S. Department of Health and Human Services, which includes the
FDA, said it’s looking to boost its capacity in this area.
Another form of artificial intelligence, generative-AI
chatbots, is also making its way into medicine. Many physicians
are now using AI to save time, such as in transcribing patient
notes. But doctors also say many patients use chatbots to
self-diagnose or challenge professional advice, posing new
challenges and risks. (See related story.)
Artificial intelligence became a business and social
sensation after the launch of ChatGPT about three years ago.
ChatGPT and other popular chatbots, such as Google’s Gemini and
Anthropic’s Claude, use so-called generative AI to create
content. They are built on top of large language models, or
LLMs, which are trained on huge troves of text and other data to
understand and generate human language. These AI tools are now
being introduced into medical areas such as consumer healthcare
AI encompasses more than LLMs, however, and the technology
made its way into medicine long before AI bots appeared. The
field dates back more than 70 years: A key moment was when
British mathematician Alan Turing asked in a 1950 paper, “Can
machines think?”
The FDA authorized its first AI-enhanced medical devices in
1995 – two systems that used pattern-matching software to screen
for cervical cancer. The type of AI used in medical devices
today is often called machine learning, along with a subset
known as deep learning, which are trained on data to perform
specific tasks. The technology is used in radiology, for
example, to enhance and analyze medical images. It can help
diagnose cancers by identifying tumors that doctors may
Such systems are also used in surgical devices. In June
2022, a surgeon inserted a small balloon into Erin Ralph’s sinus
cavity at a hospital in Fort Worth, Texas. According to a
lawsuit filed by Ralph, Dr. Marc Dean was employing the TruDi
Navigation System, which uses AI, to confirm the position of his
instruments inside her head.
The procedure, known as a sinuplasty, is a minimally
invasive technique to treat chronic sinusitis. A balloon is
inflated to enlarge the sinus cavity opening, to allow better
drainage and relieve inflammation.
But the TruDi system “misled and misdirected” Dean,
according to the lawsuit Ralph filed in Dallas County District
Court against Acclarent and other defendants. A carotid artery –
which supplies blood to the brain, face and neck – allegedly was
injured, leading to a blood clot. According to a court filing,
Ralph’s lawyer told a judge that Dean’s own records showed he
“had no idea he was anywhere near the carotid artery.” Reuters
wasn’t able to review the records, which are subject to a
judicial protective order.
After Ralph left the hospital, it became apparent that she
had suffered a stroke. The mother of four returned and spent
five days in intensive care, according to a GoFundMe fundraising
drive that was organized to support her recovery. A section of
her skull was removed “to allow her brain room to swell,” the
GoFundMe appeal stated.
“I am still working in therapy,” Ralph said in an interview
more than a year later in a blog about stroke victims. “It is
hard to walk without a brace and to get my left arm back
working, again.”
SINUPLASTY, A STROKE, AND A LAWSUIT
In May 2023, Dean was using TruDi in another sinuplasty
operation when patient Donna Fernihough’s carotid artery
allegedly “blew.” Blood “was spraying all over” – even landing
on an Acclarent representative who was observing the surgery,
according to a lawsuit Fernihough filed in U.S. District Court
in Fort Worth against Acclarent and several manufacturers. One
of Fernihough’s carotid arteries was damaged. She suffered a
stroke the day of the surgery, according to her suit.
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,” the suit alleges.
Acclarent has denied the allegations in both suits, which
are ongoing, according to court filings. The company says it did
not design or manufacture the TruDi system but only distributed
it, according to court filings. Acclarent’s owner, Integra
LifeSciences, told Reuters there’s no evidence of a link between
the AI technology and any alleged injuries.
Dean began consulting for Acclarent in 2014 and received more
than $550,000 in consultant’s fees from the company through
2024, according to Open Payments, a federal database that tracks
financial ties between companies and physicians. At least
$135,000 of those fees related to the TruDi system.
An attorney for Dean said the doctor couldn’t comment due to
patient privacy and ongoing litigation. Integra said Dean is no
longer a TruDi consultant and that payments made to him after it
acquired Acclarent were for meals.
In 2021, Acclarent’s president at the time, Jeff Hopkins,
was pushing to put AI in TruDi “as a marketing tool” to claim
that the device “had new and novel technology,” Fernihough’s
suit alleges.
The TruDi software uses machine learning to identify
specific segments of a patient’s anatomy and calculate “the
shortest, valid path between two points specified by the
physician,” according to an Acclarent post on LinkedIn. The
technology is designed to simplify surgical planning and provide
real-time feedback during procedures such as sinus operations.
Acclarent officials had approached Dean about the plan to
add AI, the Fernihough suit states. The surgeon warned Hopkins
and Acclarent “that there were issues that needed to be
resolved,” the complaint adds. Despite that warning, the suit
claims, Acclarent “lowered its safety standards to rush the new
technology to market,” and set “as a goal only 80% accuracy for
some of this new technology before integrating it into the TruDi
Navigation System.”
Reuters couldn’t establish whether Dean issued the warning.
Reporters were unable to review material submitted in support of
Fernihough’s claims, which is subject to a judicial protective
Hopkins, the former Acclarent president, did not respond to
a request for comment.
‘WRONG BODY PARTS’
The FDA cautions that reports of adverse events and device
malfunctions are limited: They often lack detail, are redacted
to protect trade secrets, and can’t be used alone to place
blame. The agency also sometimes receives multiple reports for a
single incident.
Reuters found that at least 1,401 of the reports filed to
the FDA between 2021 and October 2025 concern medical devices
that are on an FDA list of 1,357 products that use AI. The
agency says the list isn’t comprehensive. Of those reports, at
least 115 mention problems with software, algorithms or
programming.
One FDA report in June 2025 alleged that AI software used
for prenatal ultrasounds was misidentifying fetal body parts.
Called Sonio Detect, it uses machine learning techniques to help
analyze fetal images.
“Sonio detect software ai algorithm is faulty and wrongly
labels fetal structures and associates them with the wrong body
parts,” stated the report, which does not say that any patient
was harmed. Sonio Detect is owned by Samsung Medison, a unit of
Samsung Electronics. Samsung Medison said the FDA report about
Sonio Detect “does not indicate any safety issue, nor has the
FDA requested any action from Sonio.”
The HHS spokesperson didn’t respond to questions about Sonio
At least 16 reports claimed that AI-assisted heart monitors
made by medical-device giant Medtronic failed to recognize
abnormal rhythms or pauses. None of the reports mentioned
injuries. Medtronic told the FDA that some of the incidents were
caused by “user confusion.”
The AI algorithms in Medtronic’s LINQ series of implantable
cardiac monitors are described as “deep learning artificial
intelligence.” They have greatly reduced false alerts and
retained true alerts of heart events, according to the company’s
website. But the company also says on its site and in product
literature that its AI technology, AccuRhythm AI, can
misclassify actual abnormal heart rhythms or pauses.
Medtronic told Reuters that it reviewed all 16 episodes and
concluded its device only missed one abnormal heart-rhythm
event. “None of these reports resulted in patient harm,” it
said. Medtronic said some of the incidents were related to
problems with data display, not the AI technology. It declined
to explain fully what went wrong in each incident.
The HHS spokesperson said the agency doesn’t discuss
possible or ongoing compliance matters.
FDA CUTBACKS UNDER TRUMP
In interviews, five current and former FDA scientists who
reviewed AI-powered medical devices told Reuters that federal
regulators are now less equipped to handle the flood of new
About four years ago, the FDA expanded its roster of
scientists who specialize in AI, particularly for reviewing
medical imaging and radiology devices that use the technology.
Many recruits were stationed in the Division of Imaging,
Diagnostics and Software Reliability (DIDSR). The unit became
the agency’s key resource for assessing the safety of AI in
medicine, one current and two former FDA employees told Reuters.
It grew to about 40 people early last year.
“Some senior regulators have no idea how these technologies
work,” one ex-employee said. “We sat closely with senior
regulators and explained to them why we think this technology is
safe or not safe to use in the market.”
It wasn’t easy to lure top talent to government service.
Recruiting computer scientists often required persuading them to
turn down higher pay in the private sector.
In their work, scientists tried to “break” the devices’ AI
models, a former employee said. They would test a device’s
algorithms in a variety of clinical situations and check whether
the AI’s performance deteriorated over time. They also sought to
minimize “hallucinations,” in which AI models sometimes generate
false information, FDA officials wrote in a paper published in
But early last year, the Trump administration began to
dismantle the AI team as part of Elon Musk’s cost-cutting
campaign, the Department of Government Efficiency, or DOGE.
About 15 of the 40 AI scientists in the DIDSR unit were laid off
or opted to go, the FDA insiders said. Another unit that crafted
policy on devices using AI, the Digital Health Center of
Excellence, lost about a third of its staff of around 30.
Andrew Nixon, the HHS spokesperson, said the FDA is applying
the same rigorous standards to medical devices aided by machine
learning and other AI as it would to any product.
“Patient safety is the FDA’s highest priority and is at the
forefront of our work to protect and promote the public health,”
Nixon said. “The FDA sees tremendous promise in the digital
health space,” including devices enabled with AI and machine
learning, “to help diagnose and treat a range of conditions.” He
said the FDA continues to recruit and develop talent with
expertise in digital health, artificial intelligence and other
emerging technologies.
Since the cuts, the workload has nearly doubled for some
device reviewers, said two ex-employees. “If you don’t have the
resources, things are more likely to be missed,” said a former
device reviewer who left last year.
The FDA requires clinical trials for new drugs, but medical
devices face different screening. Most AI-enabled devices coming
to market aren’t required to be tested on patients, according to
FDA rules. Instead, makers satisfy FDA rules by citing
previously authorized devices that had no AI-related
capabilities, says Dr. Alexander Everhart, an instructor at
Washington University’s medical school in St. Louis and an
expert on medical device regulation.
Positioning new devices as updates on existing ones is a
long-established practice, but Everhart says AI brings new
uncertainty to the status quo.
“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.”
Published on February 9, 2026
Original source: in