{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150127", "product_res_number": "Z-0377-2017", "event_date_initiated": "2016-09-22", "event_date_created": "2016-11-09", "recall_status": "Terminated", "event_date_terminated": "2018-02-15", "res_event_number": "75178", "product_code": "FZP", "k_numbers": [ "K160454" ], "product_description": "AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip\nProduct is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.", "code_info": "Model Numbers: PRO235, PRO240, PRO245 and PRO250  Lot Numbers: 65622 to 66773", "firm_fei_number": "3011706110", "recalling_firm": "AtriCure, Inc.", "address_1": "7555 Innovation Way", "city": "Mason", "state": "OH", "postal_code": "45040-9695", "additional_info_contact": "Mr. Anupam K. Bedi\n513-755-4563", "reason_for_recall": "There is a potential for a component failure of the device which could necessitate medical intervention.", "root_cause_description": "Device Design", "action": "AtriCure sent an Urgent Advisory Notice dated September 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and determine if they have any affected product. If so customers should ensure that all users of the affected devices are aware of the Advisory Notice. If customers further distributed the product, they should identify their customers and notify them at once of the Advisory Notice. Any units from the affected lots should be returned to AtriCure, Inc. Customers should contact AtriCure customer service at 1-866-349-2342, and select option 6 to return any affected product(s). Customers were asked to complete and return the enclosed Device Notification Acknowledgement Form as soon as possible. Customers with questions should call 513-755-4563.", "product_quantity": "298", "distribution_pattern": "Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI.\n\nProduct was also shipped to the following countries: Poland and Switzerland", "openfda": { "k_number": [ "K993424", "K151943", "K102081", "K073123", "K820999", "K861922", "K931492", "K093679", "K993157", "K091060", "K050344", "K071406", "K853650", "K172479", "K982944", "K831457", "K024366", "K090872", "K984438", "K232313", "K011236", "K911915", "K031623", "K800079", "K153500", "K964109", "K030269", "K081082", "K032896", "K953908", "K053255", "K982941", "K161758", "K253903", "K812323", "K070548", "K001450", "K902108", "K834267", "K041751", "K220006", "K962043", "K841549", "K943159", "K213813", "K052018", "K242541", "K111930", "K040832", "K993135", "K841547", "K994160", "K110699", "K150996", "K841548", "K091987", "K181488", 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