Abstract
BACKGROUND: Surgeons use stereotactic image guidance systems (IGS) to help navigate complex anatomy. However, the FDA has received reports of IGS malfunction linked to operative delays and complications. We investigated FDA recalls of IGS between 2003 and 2024. METHODS: We performed a cross-sectional analysis of IGS recalls occurring between January 1, 2003, and December 1, 2024 (analytical cut-off date) using the FDA Medical Device Recalls database. For each recall, we extracted FDA-designated characteristics: disease area (otolaryngologic/neurosurgical), hazard classification (Class I-most severe/Class II-moderately severe/Class III-least severe), manufacturer, recalled units, FDA-determined cause. We calculated recall duration as the difference between initiation date and termination date (for completed recalls) or analytical cut-off date (for ongoing recalls). RESULTS: Between 2003 and 2024, there were 75 FDA recalls involving IGS authorized for sinus or skull base surgery. The majority were for neurosurgical devices (n = 59; 78.7%) and categorized as Class II (n = 69; 92.0%). Median recall duration was 121 days (IQR: 41-380 days), with 20 (26.7%) recalls extending beyond 365 days. Recalls were initiated by Medtronic (54.7%), Stryker (26.7%), Integra (13.3%), and Brainlab (5.3%); no Karl Storz (0.0%) or Fiagon (0.0%) devices were recalled. Median number of recalled units was 271 (IQR: 27-2528). The most common reason for recall was software malfunction (n = 27; 36.0%), including all 6 (100.0%) Class I (most severe) recalls. CONCLUSIONS: IGS have been subject to FDA recalls. Surgeons should avoid overreliance on IGS when planning and performing procedures. Manufacturers and FDA should resolve recalls in a timely manner to support safe surgery.