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Arrow International Indigo
No active recall
Manufacturer: Arrow International · FDA product code: DXE · Category: Catheter, Embolectomy
Severity Snapshot
30 total reports1998-08 – 2025-08 date range85.7% physician / facility reported14.3% manufacturer reported3 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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