Recall Z-1887-2019 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
AtriCure, Inc.
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
| Date | May 29, 2019 |
| 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 497 |
| Distribution | Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX Ncontact Surgical, Inc., Oct 28, 2014 |