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ELUVIA™
BOSTON SCIENTIFIC CORPORATION · Model H74939294601070 · UDI-DI 08714729876540
NIU
Prescription
0
510(k) clearances
2,846
Adverse events (16 deaths)
3
Recalls
10
Facilities
Description
Drug-Eluting Vascular Stent System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-21 | Boston Scientific Corporation | One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging. |
| 2013-04-18 | Cook, Inc. | Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system in |
| 2013-04-18 | Cook, Inc. | Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system in |
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Get your free API keyRead the docsData 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.