FDA Medical Device Recalls (openFDA)
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 number
- Z-1621-2021
- Recalling firm
- Boston Scientific Corporation
- 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.
- Status
- Terminated
- Initiated
- 2021-04-21
- Posted
- not on file
- Terminated
- 2023-08-07
- Reason
- One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
- Root cause
- Reprocessing Controls
- 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.
- Quantity
- 27 UNITS
- 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.
- Lot, serial or model codes
- LOT: 25838357
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NIU
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28