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Cook Medical Cook Spectrum
No active recall
Manufacturer: Cook Medical · FDA product code: FOZ · Category: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Severity Snapshot
168 total reports2016-04 – 2025-10 date range17.5% physician / facility reported82.5% 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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