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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
Related recalls
Same manufacturer · AtriCure, Inc.
See all →- HighCryo Module Tank Hose Assemblies Recalled for Material and Design Defects
FDA (Devices) · 2024-02-07
- HighTank hose assembly recalled for incorrect material and missing perforations
FDA (Devices) · 2024-02-07
- SevereAtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk
FDA (Devices) · 2019-02-20
- HighAtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk
FDA (Devices) · 2019-02-20
- HighAtriCure Recalls COBRA FUSION 50 Ablation Systems Due to Thromboembolism Risk
FDA (Devices) · 2019-02-20
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighVitriGuard Cryopreservation Storage Device Recalled for Sterility Risk
FDA (Devices) · 2022-05-25
- SevereAtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk
FDA (Devices) · 2019-02-20
- HighCooperSurgical Retractor System Elastic Stays Recalled for Potential Seal Compromise
FDA (Devices) · 2018-10-03
- HighAtriCure Recalls COBRA FUSION 50 Ablation Systems Due to Thromboembolism Risk
FDA (Devices) · 2019-02-20
- HighSurgical Sutures Recalled for Sterility Compromise During Transit
FDA (Devices) · 2024-04-24
- HighStryker Endotrac ECTR Push Blade Recalled for Sterile Bag Seal Integrity
FDA (Devices) · 2019-09-04