# FDA recall Z-1529-2021

> **LeMaitre Vascular, Inc.** · Class II · device recall initiated 2021-04-06.

## Product

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.

## Reason for recall

The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.

## Key facts

- **Recall number:** Z-1529-2021
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-06
- **Report date:** 2021-05-12
- **Termination date:** 2022-12-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burlington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2021

## Citation

> AI Analytics. FDA recall Z-1529-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1529-2021. Source: US FDA. Licensed CC0.

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