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Boston Scientific Corporation recalls ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of
Recalled May 26, 2021 · FDA recall Z-1621-2021 · Boston Scientific
Hazard
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging. · FDA Class II
Units
27 UNITS
Sold at
US Nationwide distribution in the states of AL, AR, AZ, CA, DE, HI, IL, KS, KY, MA, MD, NC, NJ, NV, NY, OH, OK, PA,PR, TX, VA,WA,WV.
Description
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Product
ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion lengths up to 190 mm.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →