Boston Scientific Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
LOT: 25838357
Products Sold
LOT: 25838357
Boston Scientific Corporation is recalling ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter due to One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026