Overview
- FDA filings reviewed by Reuters document at least 100 malfunctions and at least 10 patient injuries reported from late 2021 to November 2025 after AI was added to Acclarent’s TruDi Navigation System.
- Reported events describe the system misinforming surgeons about instrument location, with injuries including cerebrospinal fluid leaks, skull base punctures and strokes.
- Two patients, Erin Ralph and Donna Fernihough, filed Texas lawsuits alleging strokes after procedures involving TruDi, claiming the device was less safe after its AI software changes.
- Integra LifeSciences, which acquired Acclarent in 2024, disputes any causal link and the FDA notes adverse-event reports do not establish causation.
- Reuters counts roughly 1,357 FDA‑authorized AI-enabled devices, about double since 2022, while a Johns Hopkins–Georgetown–Yale study ties 60 AI devices to 182 recalls with 43% occurring within a year and former FDA staff report capacity strains.