BAROSTIM NEO Adverse Events: FDA MAUDE Data

CVRX, INC. · Carotid Sinus Nerve Stimulator (Barostim) · First cleared Jan 2024

Total Reports

102

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Evidence

Related research

Non-clinical and Pre-clinical Testing to Demonstrate Safety of the Barostim Neo Electrode for Activation of Carotid Baroreceptors in Chronic Human Implants.

Wilks SJ, et al. · 2017

Old problem surfaces with new technology: Twiddler's syndrome in Barostim NEO.

Rao A, et al. · 2024

Efficacy of carotid devices for resistant hypertension: a systematic review.

Kayir I, et al. · 2026

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.