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G4 Steerable Guiding Catheter
No active recall
FDA product code: DRA · Category: Catheter, Steerable
Severity Snapshot
1,158 total reports2020-04 – 2025-11 date range71.8% physician / facility reported28.2% manufacturer reported2 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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