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Medtronic Enroute Transcarotid Neuroprotection
No active recall
Manufacturer: Medtronic · FDA product code: NTE · Category: Temporary Carotid Catheter For Embolic Capture
Severity Snapshot
611 total reports2016-04 – 2026-03 date range83.5% physician / facility reported16.5% manufacturer reported2 SKU variants
Reporting Trend
Annual Reporting Volume
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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.
Reported Events
Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.
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