Manufacturer
13 recalls in our database name AtriCure, Inc. as the manufacturing or recalling firm.
Of the 13 recalls from AtriCure, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (23%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.
AtriCure recalls certain tank hose assemblies for Cryo Module equipment due to manufacturing defects. The units have incorrect inner tube material and missing required perforations on the outer sheathing.
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.
AtriCure is recalling 765 units of the COBRA FUSION 150 Ablation System due to a potential elevated risk of thromboembolism during specific off-pump procedures.
AtriCure is recalling 6,176 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.
AtriCure is recalling 1,288 COBRA FUSION 50 Ablation Systems because patients may face an elevated risk of thromboembolism during specific off-pump procedures.
AtriCure is recalling 175 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.
AtriCure is recalling 464 AtriClip LAA Exclusion System devices because a complaint was received regarding the PRO2 jaw breaking prior to surgery.
AtriCure is recalling COBRA Fusion Ablation Systems because a part may separate and remain in the body, potentially causing permanent impairment or damage.
AtriCure, Inc. is recalling 298 AtriClip LAA Exclusion Systems due to a potential component failure that could require medical intervention.
Atricure Inc is recalling 19,190 CryoICE cryogenic probes due to packaging defects that may have compromised sterility.
AtriCure is recalling 46 Reusable Clip Appliers because a customer reported a cracked spring in the handle. The devices were distributed nationwide.
Atricure Inc. is recalling five Max1 Isolator Transpolar Pens due to incorrect Instructions for Use labeling.