FDAMay 29, 2019device
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 tiss...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
atricure
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACryo Module Accessories Domestic CMA-OUS, Product Catalog Number A0010532023-11-28
- FDAPackaged, Tank Hose Assembly CMA-US, Product Catalog Number A0010562023-11-28
- FDACOBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S2019-01-22
- FDACOBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI2019-01-22
- FDACOBRA FUSION 50, Ablation System, Catalog # (REF) 700-0022019-01-22
- FDACOBRA FUSION 150 Ablation System, Catalog # (REF) 700-0012019-01-22
- FDAAtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 d...2016-11-30
- FDAAtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.2016-09-22
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →