2095 Systematic Review on Trends in FDA Regulatory Pathways and Recalls for Neuroendovascular Devices From 2002-2025

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INTRODUCTION: Rapid innovation in endovascular neurosurgery has coincided with major shifts in FDA regulatory oversight. However, limited quantitative data exist on approval pathways and recall outcomes specific to neuroendovascular devices. METHODS: FDA Medical Device Databases were queried from November 2002 to May 2025. Of 291 neurologic product codes, 20 relevant to endovascular neurosurgery were identified. Each was assessed for humanitarian device exemptions (HDE), de novo clearances, premarket approvals (PMA), 510(k) notifications, and recalls. Descriptive statistics, recall-to-approval ratios, and Class I recall rates were calculated. Two-proportion z-tests were used to assess significance. RESULTS: 836 approvals and 125 recalls were identified. Recall volume peaked in 2015–2016 (224% increase), corresponding with increased thrombectomy use after the HERMES trials. Most approvals (56%) used the 510(k) pathway, while de novo was rarely used (0.24%). Of all Class I recalls, 68% involved 510(k)-cleared devices and 32% PMA-approved. Neurovascular stents accounted for 96% of HDEs and 24% of all approvals. The highest recall-to-approval ratio was seen in 510(k) devices (0.233; p < 0.00001), with no significant difference between PMA (p = 0.077) and HDE (p = 0.064). CONCLUSIONS: The de novo pathway remains underutilized, while 510(k)-cleared devices show disproportionately high recall-to-approval ratios. HDE and PMA approvals share similar recall ratios, despite HDE’s lower market entry barriers and distribution restrictions. Encouraging de novo use for catheter approvals and creating intermediate pathways between HDE and PMA may enhance safety, limit off-label cardiac stent use, and support innovation in endovascular neurosurgery.

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