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.
FDA Recall Z-1621-2021 · Posted None
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeNIU
Date Initiated2021-04-21
Date Terminated2023-08-07
Product Quantity27 UNITS
Reason for Recall
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Firm Action
On April 21, 2021 the firm sent a letter to its customers with Immediate Action Required with the following instructions:
If you identify any product from the listed batch within your inventory, please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed instructions. You will receive replacement product for all removed product returned to Boston Scientific.
If you are a distributor, please note that the removal depth is to the hospital level and the removal notification should be forwarded to your customers.
Root Cause
Reprocessing Controls
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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