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AVVIGO™ Guidance System

BOSTON SCIENTIFIC CORPORATION · Model H749009761Z0 · UDI-DI 08714729996552

DSKDQK Prescription
10
510(k) clearances
546
Adverse events (3 deaths)
1
Recalls
100
Facilities

Recalls

DateFirmReason
2012-05-04Argon Medical Devices, IncSome of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.

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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.