FDANovember 28, 2023device
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
What to do
FDA enforcement status: Ongoing
Brands named
atricure
UPCs
10840143903038
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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 150 Ablation System, Catalog # (REF) 700-0012019-01-22
- 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) 700-001S2019-01-22
- 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
- FDACOBRA 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...2016-09-22
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