EPi-Sense Guided Coagulation System with Visitrax — Class II medical device recall Z-1887-2019
Terminated recall by AtriCure, Inc., reported 2019-07-03, distributed nationwide. The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case
| Recall number | Z-1887-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AtriCure, Inc., Mason, OH, United States |
| Recall initiated | 2019-05-29 |
| Classified | 2019-06-26 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2020-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, NL |
| Quantity | 497 |
| Reason classes | sterility, packaging |
| Lot numbers | 70638, 71332, 89208, 89938, 90624 |
| Model numbers | CDK-1413 |
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 techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1887-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.