AtriCure EPi-Sense Guided Coagulation System Recalled for Compromised Sterile Seal
AtriCure is recalling 497 units of the EPi-Sense Guided Coagulation System because the sterile package seal may be compromised, posing a risk of infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection) where injury has not yet been reported, which aligns with the High severity criteria for risk-of-harm products without reported illness.
Plain-English summary
AtriCure, Inc. is recalling 497 units of the EPi-Sense Guided Coagulation System with VisiTrax, Model No. CDK-1413. The recall involves specific lots (70638, 71332, 89208, 89938, 90624) that were distributed nationwide in the United States, as well as in Germany and the Netherlands.
The recall was initiated because the sterile package seal for the device may be compromised. The EPi-Sense system is a sterile, single-use, disposable coagulation electrode device intended to be used to coagulate cardiac tissue using radiofrequency energy. If the sterile seal is compromised and the device is used, there is a risk of infection.
Healthcare providers and facilities that have purchased or received these specific lots should stop using the affected devices and contact AtriCure, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- 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 coagu
- Manufacturer
- AtriCure, Inc.
- Affected units
- 497
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots 70638
- 71332
- 89208
- 89938
- 90624
Distribution
Distributed nationwide across the United States.
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