# FDA recall Z-1491-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2022-05-25.

## Product

EkoSonic Kit 135cm, 12cm TZ    The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components.  They are placed into the respective trays and sealed in a Tyvek pouch.  The sealed pouches are placed inside the kit carton (box) and the product labels.

## Reason for recall

Product may be mislabeled.

## Distribution

US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY

## Key facts

- **Recall number:** Z-1491-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-25
- **Report date:** 2022-08-10

- **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-1491-2022

## Citation

> AI Analytics. FDA recall Z-1491-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1491-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*