Z-1621-2021Class II

ELUVIA Drug-Eluting Vascular Stent System -

Name: Z-1621-2021 ELUVIA Drug-Eluting Vascular Stent System -
Creator: Boston Scientific Corporation
Published: 2021-04-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-04-21 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic... on 2021-04-21. FDA classified it as Class II and gives the reason as "One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1621-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-21
Posted: 2021-05-18
Terminated: 2023-08-07
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.
Product code: NIU Stent, Superficial Femoral Artery, Drug-Eluting
Reason for recall: One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: LOT: 25838357

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1621-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1621-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-18

Product code NIU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)