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Medtronic Rosa One
No active recall
Manufacturer: Medtronic · FDA product code: HAW · Category: Neurological Stereotaxic Instrument
Severity Snapshot
609 total reports2017-11 – 2026-03 date range8.1% physician / facility reported91.9% manufacturer reported5 SKU variants
Failure & Consequence Profiles
Top Failure Modes
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Top Patient Outcomes
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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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