EPi-Sense Coagulation System (AtriCure) – package seal risk (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Instrum
Brand
AtriCure, Inc.
Lot Codes / Batch Numbers
Lots 70638, 71332, 89208, 89938, 90624
Products Sold
Lots 70638, 71332, 89208, 89938, 90624
AtriCure, Inc. is recalling EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 29, 2019, the firm notified customers of the recall via Urgent Advisory Notice. Customers were asked to take the following actions: " Immediately quarantine any affected product as identified within this Advisory Notice. " Contact AtriCure product complaints by phone at 1-866-349-2342 (select option 6) or e-mail to pcomplaints@atricure.com to request a Return Goods Authorization (RGA). " Return the attached Acknowledgement Form. See Attachment B. The acknowledgement form must be completed and returned even if product is not on hand by selecting the second option. " Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions, please contact Rob Cantu, Vice President of Quality at (1-513-644-4245) from 9-6pm ET on Mondays - Fridays. You may also contact customer service at (1-866-349-2342) any time of day, your message will be forwarded to Quality Assurance for review promptly. This advisory issue will also be posted on AtriCures website at www.atricure.com/products.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026