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Arrow International Indigo System Aspiration Catheter D

No active recall

Manufacturer: Arrow International  · FDA product code: DXE  · Category: Catheter, Embolectomy

Severity Snapshot

33 total reports2017-042021-11 date range3% physician / facility reported97% 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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