FDA Device recall Z-1621-2021
ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo…
- FDA Device
- Class II
- terminated
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo… by Boston Scientific, citing one batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1621-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-21 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
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.
Reason
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Identifiers
| code_info | LOT: 25838357 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1621-2021%22
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