{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "221276", "product_res_number": "Z-2806-2026", "event_date_initiated": "2026-06-24", "event_date_posted": "2026-07-27", "recall_status": "Open, Classified", "res_event_number": "99320", "product_code": "DWF", "k_numbers": [ "K031037" ], "product_description": "EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422", "code_info": "UDI-DI: 20763000135632,\nLot Numbers: 0232446429\n0232446444\n0232486752\n0232601515\n0232601516\n0232601522\n0232601586\n0232601591\n0232601593\n0232602180\n0232798265\n0232798353\n0232849583\n0232894981\n0232895082\n0232902694\n0232902697\n0232902698\n0232902700\n0232902803\n0232902805\n0232902846\n0232985469\n0233009922\n0233108251\n0233116991\n0233127352\n0233334923\n0233334966\n0233426694\n0233426695\n0233528727;\nUDI-DI: 00763000135638,\nLot Numbers: 0232446444\n0232798353\n0232895082\n0232902697\n0232902803\n0232902846\n0232985469\n0233127352\n0233334923", "firm_fei_number": "1000116158", "recalling_firm": "Medtronic Perfusion Systems", "address_1": "7611 Northland Dr N", "city": "Brooklyn Park", "state": "MN", "postal_code": "55428-1088", "additional_info_contact": "Medtronic Customer Service\n391-9001", "reason_for_recall": "Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT: MEDICAL DEVICE RECALL notification letter dated June 2026 was sent to customers beginning 6/24/26.\n\nCustomer Actions:\nMedtronic requests that you take the following actions:\n\" Review your inventory for listed products using Attachment A.\n\" Immediately identify and quarantine all unused, listed product in your inventory.\n\" Return unused, listed product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return for credit or replacement product. Your Medtronic sales representative can assist you in the return of affected product as necessary.\n\" Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have any affected product in your possession.\n\" Please share this notification with others in your organization as appropriate. If the product listed above has been forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.\n\" Please maintain a copy of this communication in your records.\n\nIf you have any questions regarding this communication, please contact 1-800-854-3570, Option 1, then Option 4.", "product_quantity": "21,290 units", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K802543", "K971021", "K792202", "K993677", "K832124", "K915193", "K850356", "K955818", "K850385", "K923483", "K840001", "K831130", "K951088", "K013593", "K080034", "K043179", "K896636", "K020515", "K200499", "K950814", "K850917", "K110983", "K880779", "K964248", "K781990", "K844138", "K062597", "K862634", "K813037", "K865079", "K843444", "K253998", "K081881", "K132811", "K970914", "K102420", "K032977", "K181150", "K063618", "K972503", "K140208", "K143083", "K002578", "K000830", "K840002", "K863342", "K955121", "K150422", "K850925", 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