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Terumo Azur Hydropack 18
No active recall
Manufacturer: Terumo · FDA product code: KRD · Category: Device, Vascular, For Promoting Embolization
Severity Snapshot
14 total reports2024-03 – 2026-03 date range91.7% physician / facility reported8.3% manufacturer reported3 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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