Class II — AtriCure, Inc.
| Recalling firm | ATRICURE, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 electro… |
| Quantity | 497 |
| Distribution | Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands. |
| Initiated | 2019-05-29 |
| Classified | 2019-06-26 |
| Terminated | 2020-05-04 |
| Recall number | Z-1887-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AtriCure, Inc. (Z-1887-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83021/
Alerts for ATRICURE, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.