FDASeptember 22, 2016device
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to th...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.
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
- FDAEPi-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...2019-05-29
- FDACOBRA FUSION 50, Ablation System, Catalog # (REF) 700-0022019-01-22
- FDACOBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI2019-01-22
- FDACOBRA FUSION 150 Ablation System, Catalog # (REF) 700-0012019-01-22
- FDACOBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S2019-01-22
- 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
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