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Fluency® Endovascular Stent Graft

Bard Peripheral Vascular, Inc. · Model FEL06120 · UDI-DI 04049519008073

PFV Prescription
0
510(k) clearances
2,731
Adverse events (31 deaths)
1
Recalls
16
Facilities

Description

FLUENCY® PLUS Endovascular Stent Graft 6 mm x 120 mm (117 cm delivery system)

Recalls

DateFirmReason
2022-12-22Bard Peripheral Vascular IncAn increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.