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Arrow International Indigo System Aspiration Catheter 6
No active recall
Manufacturer: Arrow International · FDA product code: DXE · Category: Catheter, Embolectomy
Severity Snapshot
396 total reports2015-10 – 2021-09 date range0.3% physician / facility reported99.7% 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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