# FDA recall Z-1887-2019

> **AtriCure, Inc.** · Class II · device recall initiated 2019-05-29.

## Product

EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniq

## Reason for recall

The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.

## Distribution

Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands.

## Key facts

- **Recall number:** Z-1887-2019
- **Recalling firm:** AtriCure, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-29
- **Report date:** 2019-07-03
- **Termination date:** 2020-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mason, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1887-2019

## Citation

> AI Analytics. FDA recall Z-1887-2019. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1887-2019. Source: US FDA. Licensed CC0.

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