{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121971", "product_res_number": "Z-0091-2014", "event_date_initiated": "2013-09-16", "event_date_posted": "2013-10-31", "recall_status": "Terminated", "event_date_terminated": "2017-03-10", "res_event_number": "66305", "product_code": "DWF", "k_numbers": [ "K022071", "K102420" ], "product_description": "Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.\n\nThe EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.", "code_info": "Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.", "firm_fei_number": "1713910", "recalling_firm": "Edwards Lifesciences, LLC", "address_1": "12050 Lone Peak Pkwy", "city": "Draper", "state": "UT", "postal_code": "84020-9414", "additional_info_contact": "Suzanne Carpenter\n801-565-6100", "reason_for_recall": "Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, Edwards Lifesciences, sent an \"URGENT FIELD SAFETY NOTICE PRODUCT RECALL-ACTION REQUIRED\" letter dated September 16, 2013 via Fed-Ex to its consignees/customers. Consignees were asked to review inventory for the cannulae and remove the cannulae from any kits received; quarantine affected material at site and return product to Edwards LIfesciences, Attn: Santosh Bhagat, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA #; call Edwards Customer Service at 800-424-3278 to obtain RGA# and replacement product (note: the filter is not affected and does not have to be returned with the cannulae); and complete and return the attached acknowledgment form via fax to Edwards Customer Service at 800-422-9329 within three days of receipt of this Field Safety Notice.\n\nIf you have any questions, please call Edwards Customer Service at 800-424-3278 from the hours 6:00am - 4:30pm PST or contact your Edwards' sales representative concerning the recall.", "product_quantity": "12,034", "distribution_pattern": "Worldwide distribution: US (nationwide) and country of: Canada.", "openfda": { "k_number": [ "K203057", "K971019", "K801359", "K983270", 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"3005426550", "3001665800", "3000204775" ], "device_name": "Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4210", "device_class": "2" } } ] }