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Flexcath Advance Steerable Sheath
No active recall
FDA product code: DRA · Category: Catheter, Steerable
Severity Snapshot
2,922 total reports2013-03 – 2026-03 date range28.3% physician / facility reported71.7% manufacturer reported1 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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