FDA Recalls of Image Guidance Systems for Sinus and Skull Base Surgery, 2003-2024

Area of Science:

• Neurosurgery
• Medical Device Technology
• Surgical Navigation

Background:

• Stereotactic image guidance systems (IGS) are crucial for navigating complex surgical anatomy.
• The U.S. Food and Drug Administration (FDA) has documented malfunctions in IGS, leading to surgical delays and complications.
• This study analyzes FDA recalls of IGS from 2003 to 2024.

Purpose of the Study:

• To investigate the frequency and characteristics of FDA recalls for image guidance systems (IGS).
• To identify the primary causes and manufacturers associated with IGS recalls.
• To assess the duration and impact of IGS recalls on surgical practice.

Main Methods:

• A cross-sectional analysis of FDA Medical Device Recalls database from January 1, 2003, to December 1, 2024.
• Extracted data included disease area, hazard classification, manufacturer, recalled units, and cause of recall.
• Recall duration was calculated from initiation to termination or the analytical cut-off date.

Main Results:

• 75 FDA recalls of IGS for sinus or skull base surgery were identified between 2003 and 2024.
• Neurosurgical devices constituted the majority (78.7%) of recalls, predominantly Class II (92.0%).
• Software malfunction was the leading cause (36.0%), accounting for all Class I recalls; median recall duration was 121 days.

Conclusions:

• Image guidance systems (IGS) are subject to significant FDA recalls, impacting surgical procedures.
• Surgeons should exercise caution and avoid overreliance on IGS during surgical planning and execution.
• Timely resolution of recalls by manufacturers and the FDA is essential for ensuring surgical safety.