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Bard Gelsoft
No active recall
Manufacturer: Bard · FDA product code: MAL · Category: Graft, Vascular, Synthetic/Biologic Composite
Severity Snapshot
20 total reports2013-11 – 2021-11 date range5% physician / facility reported95% 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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