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GORE VIABAHN Endoprosthesis

W. L. Gore & Associates, Inc. · Model VBCR061002A · UDI-DI 00733132623402

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

Description

VIABAHN SX ENDO 35 RO 6mmX10cm 7Fr 120cmCath

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.