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Embozene Microspheres (Opaque)

CELONOVA BIOSCIENCES, INC. · Model 113010-S0 · UDI-DI 00879397003402

NAJKRD
8
510(k) clearances
477
Adverse events (18 deaths)
1
Recalls
18
Facilities

Description

Microspheres for Embolization

Recalls

DateFirmReason
2009-08-17Boston Scientific CorporationCompromised sterility: Boston Scientific is initiating a Recall Removal for twenty (20) UPN codes and 638 associated lots/batches of its Contour SE Microspheres product. All affe

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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.