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Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis
Lokeshwar S Bhenderu1, Paras Gupta2, Andrew Schindler2
1Department of Neurological Surgery, Houston Methodist Hospital, Houston, Texas, USA.
Background And Objectives:
The neurosurgery landscape has witnessed substantial advancements in recent years, with an increasing reliance on medical devices to enhance surgical safety and efficacy. However, alongside this progress, there has been a rise in the number of device recalls, prompting a need for comprehensive analysis to understand the underlying trends and factors contributing to these recalls. This quantitative review aimed to analyze 2 decades of U.S. Food and Drug Administration (FDA) recall data within neurosurgery to identify patterns and trends in device recalls. By examining the frequency, timing, and reason for recalls, we sought to identify the specific types of neurosurgical devices that are most often recalled.
Methods:
Using the openFDA device recalls database, we queried recall data for neurosurgical devices from January 2003 to December 2022. Recalls were categorized based on device specialty and reason, with validation by neurosurgical experts by the FDA medical device recalls database. The analysis focused on identifying peaks and trends in recall frequencies over the study period.
Results:
A total of 412 unique neurosurgical device recalls were identified from 2003 to 2022. Recalls increased until 2013, then declined through 2022. General neurosurgery devices accounted for the largest proportion (168, 40.8%), followed by stereotaxic (94, 22.8%) and functional (79, 19.2%) devices, consistently making up the largest share each year. Most recalls were class II (362, 87.9%), followed by class I (28) and class III (22). The most common cause was process errors (67, 14.8%), followed by issues with components/materials (56, 13.6%), device design (61, 14.8%), and labeling (50, 12.1%). Marketing-related issues were least frequent (16, 3.9%).
Conclusion:
General neurosurgery devices accounted for the highest recall rates, warranting closer evaluation of contributing factors. Process errors were the leading cause, with most being class II recalls. Understanding recall patterns can help guide strategies to improve device safety and reduce patient risk.