Boston Scientific Corporation Recall 87839
Description: 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.
Boston Scientific Corporation Recall 87839 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1621-2021 |
| Event ID | 87839 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 27 UNITS |
| Recall Reason | One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging. |
| Device Classification | 20210526 |
| Device Code Info | LOT: 25838357 |
| Center Classification Date | 20210518 |
| Recall Initiation Date | 20210421 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
| Similar To |