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Flair® Endovascular Stent Graft

Bard Peripheral Vascular, Inc. · Model FAS06070 · UDI-DI 04049519008929

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

Description

FLAIR® Endovascular Stent Graft 6 mm x 70 mm (80 cm delivery catheter)(straight)

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.