# FDA recall Z-3042-2018

> **LeMaitre Vascular, Inc.** · Class II · device recall initiated 2018-06-19.

## Product

AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.

## Reason for recall

The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.

## Distribution

Distributed to accounts in FL, NV, OK, SC, and TX.

## Key facts

- **Recall number:** Z-3042-2018
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-19
- **Report date:** 2018-09-19
- **Termination date:** 2019-04-17

- **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-3042-2018

## Citation

> AI Analytics. FDA recall Z-3042-2018. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-3042-2018. Source: US FDA. Licensed CC0.

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