—#187223

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.

FDA product code: NIU — Stent, Superficial Femoral Artery, Drug-Eluting
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: LOT: 25838357

Why it was recalled

One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

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.

Timeline

Recall initiated: 2021-04-21
Terminated: 2023-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187223. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.