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Arrow International Angiojet® Solent Omni
No active recall
Manufacturer: Arrow International · FDA product code: DXE · Category: Catheter, Embolectomy
Severity Snapshot
298 total reports2015-08 – 2018-09 date range0% physician / facility reported100% 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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