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Express® SD Renal/Biliary

BOSTON SCIENTIFIC CORPORATION · Model H74937912719150 · UDI-DI 08714729390510

NINFGE Prescription
0
510(k) clearances
874
Adverse events (32 deaths)
1
Recalls
16
Facilities

Description

Premounted Stent System

Recalls

DateFirmReason
2020-04-15Cook Inc.The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead

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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.