# FDA recall Z-1621-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-04-21.

## 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 for recall

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

## 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.

## Key facts

- **Recall number:** Z-1621-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-21
- **Report date:** 2021-05-26
- **Termination date:** 2023-08-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1621-2021

## Citation

> AI Analytics. FDA recall Z-1621-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1621-2021. Source: US FDA. Licensed CC0.

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