{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216369", "product_res_number": "Z-0487-2026", "event_date_initiated": "2025-09-12", "event_date_posted": "2025-11-10", "recall_status": "Open, Classified", "res_event_number": "97702", "product_code": "DTZ", "k_numbers": [ "K241352" ], "product_description": "Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B", "code_info": "Lot Number: 231621003;\nUnit Serial Number: 5117755016;\nUDI-DI: 00763000187842, 20763000187846", "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\n800-854-3570", "reason_for_recall": "Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.", "root_cause_description": "Under Investigation by firm", "action": "An Urgent: Medical Device Recall notification letter dated September 2025 was sent to customers.\n\nPatient Recommendations:\nPatient previously supported with the impacted device face no additional risk from the issue described in this communication and should continue to be monitored per your practice s normal follow-up procedures.\n\nCustomer Actions:\nMedtronic requests that you take the following actions:\n Review your inventory for listed lot number.\n If your inventory contains a product with Lot Number 231621003, please refer to the NT Affinity Oxygenator to identify the Serial Number. For guidance, consult Attachment A Identifying Affected Product.\n If you have the unit with Serial Number 5117755016 immediately quarantine and return it to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return and exchange or credit of this unit. Your Medtronic sales representative can assist you in the return of unit as necessary.\n Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com.\nThis form must be returned even if you do not have the affected product in your possession.\n Please maintain a copy of this communication in your records.\n\nMedtronic: Report complaints at 1-800-854-3570, option 4, or email to rs.structuralheartfieldassurance@medtronic.com.\n\nIf you have any questions regarding this communication, please contact your Medtronic Field Representative.", "product_quantity": "26 units", "distribution_pattern": "US States: AZ, CA, TN", "openfda": { "k_number": [ "K140181", "K014080", "K970463", "K843956", "K231982", "K781223", "K925626", "K923272", "K772284", "K803231", "K071494", "K241352", "K022115", "K844901", "K242503", "K926467", "K912078", "K810505", "K201642", "K980974", "K831705", "K810532", "K172984", "K231773", "K860673", "K760824", "K896978", "K961000", "K991452", "K910107", "K130209", "K071774", "K963518", "K203424", "K954850", "K000430", "K130359", "K112360", "K971877", "K925076", "K130333", "K162016", "K896671", "K894630", "K861641", "K812660", "K964043", "K926226", "K123314", "K191444", "K172071", "K102464", "K072091", "K031903", "K872133", "K082117", "K901253", "K903436", "K912655", "K862918", "K962667", "K101153", "K830639", "K080708", "K022450", "K030264", "K231414", "K143073", "K843955", "K020997", "K133261", "K882892", "K861177", "K895393", "K200109", "K780078", "K122827", "K883053", "K202206", "K810470", "K130493", "K180950", "K010478", "K141492", "K142784", "K941653", "K071572", "K031223", "K090511", "K901249", "K200683", "K960074", "K083021", "K823125", "K953835", "K890808", "K253838", "K013480", "K801240", "K831894", "K863249", "K912079", "K183490", "K061628", "K831895", "K872107", "K961734", "K830327", "K130280", "K023381", "K853080", "K821477", "K823456", "K883054", "K920889", "K240666", "K153295", "K931444", "K841476", "K912920", "K010443", "K833670", "K951247", "K043323", "K934292", "K790406", "K873923", "K130433", "K082403", "K897068", "K802970", "K891687", "K901250", "K100278", "K153213", "K090689", "K823343", "K090449", "K001021", "K964967", "K121536", "K250821", "K811004", "K153140", "K912082", "K941473", "K132829", "K051997", "K894826", "K000255", "K973760", "K933586", "K072362", "K151713", "K781842", "K893207", "K974812", "K894103", "K113626", "K962641", "K802328", "K974085", "K013038", "K802720", "K821216", "K925075", "K901624", "K130520", "K121229", "K211495", "K823273", "K892641", "K922933", "K790356", "K854045", "K223161", "K992910", "K172626", "K162896", "K993772", "K230640", "K874841", "K895632", "K231652", "K922799", "K802719", "K062381", "K222297", "K061031", "K851035", "K103191", "K190690", "K201916", "K121909", "K120185", "K772237", "K991737", "K853251", "K050447", "K990103", "K102109", "K090450", "K892664", "K040210", "K992559", "K020351", "K863476", "K033323", "K122844", "K833518", "K151389", "K894970", "K150267", "K202510", "K891230", "K093522", "K151791", "K833078", "K860539", "K961530", "K004001", "K932252", "K984271", "K092895", "K800555", "K240934", "K100645", "K140177", "K864235", "K911227", "K073380", "K183511", "K203111", "K180448", "K122254", "K150489", "K013915", "K191029", "K212341", "K953976", "K842908", "K833253", "K803003", "K813255", "K893704", "K863515", "K792039", "K850630", "K941225", "K880021", "K191246", "K822803", "K831122", "K140774" ], "registration_number": [ "3021599320", "9617601", "3019807891", "2184009", "3003752502", "1218444", "1928237", "3009507273", "1643817", "3030125051", "3011554160", "3008307705", "8010762", "9681834", "9680841", "3015136750", "3002807090", "3045892899", "2528981", "3002806603", "3014990448", "1124841", "1220648", "3010155661", "3013267343", "1319639", "1625519", "3010163695", "3005941719", "3016746283", "2011171", "2916596", "8010026", "3044156918" ], "fei_number": [ "3021599320", "3009649876", "3019807891", "3003752502", "1218444", "2828", "1000116158", "1928237", "3009507273", "1643817", "1000138054", "3030125051", "3006003617", "3011554160", "3008307705", "3015136750", "3045892899", "3002808327", "3005426550", "2528981", "3002806603", "3002534070", "3014990448", "1220648", "3010155661", "3002807111", "3013267343", "1625519", "3010163695", "3016746283", "2011171", "2916596", "3044156918", "3000204839" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }