{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "197519", "product_res_number": "Z-1023-2023", "event_date_initiated": "2022-12-12", "event_date_posted": "2023-01-27", "recall_status": "Open, Classified", "res_event_number": "91343", "product_code": "DTZ", "k_numbers": [ "K203111" ], "product_description": "Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.", "code_info": "Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169178168 (Lot Numbers: 13386860, 13386998, 13387454, 223834103, 224773022, 224773023, 225467084, 225467085); GTIN Number: 00643169178175 (Lot Number: 13388339, 13389098, 13394289, 223815345, 223829391, 223834104, 223834105, 224602715, 224695594, 224702830, 224711400, 224773018, 224773019, 224773020, 224773021, 224875617, 224883237, 224893902)", "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": "An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.", "root_cause_description": "Process change control", "action": "Medtronic initially notified consignees on 12/12/2022 and followed up with an updated notification on 12/21/2022. Consignees were advised of two options: 1. Continue to use the Affinity Fusion Oxygenator without using the TMA (use other conventional perfusion circuit temperature monitoring methods); or 2. Continue to use the Affinity Fusion Oxygenator and the TMA for arterial temperature monitoring. Ensure there is minimal torque applied to the oxygenator TMA when attaching or detaching the Temperature Probe (Product Number ATP210). Also, minimize manipulation of the TMA-probe connection during the clinical procedure. Consignees were also advised to complete and return the Customer Confirmation Form, and notify personnel or facilities were affected units are located. \n\nOn about 02/10/2023, Medtronic initiated an expansion and notified customers. Instructions in the customer letter remained the same.", "product_quantity": "2,937 units", "distribution_pattern": "Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Honduras, Hungary, Iceland, Indonesia, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, Turkmenistan, Uganda, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Yemen.", "openfda": { "k_number": [ "K861177", "K962667", "K851035", "K000430", "K121536", "K830639", "K140774", "K941653", "K150267", "K911227", "K974085", "K223161", "K162896", "K061031", "K100645", "K201916", "K022115", "K893704", "K071494", "K072362", "K964967", "K850630", "K090449", "K863476", "K101153", "K122844", "K250821", "K863249", "K896671", "K130359", "K812660", "K183511", "K231982", "K803003", "K231773", "K853251", "K962641", "K810470", "K860673", "K841476", "K072091", "K020997", "K833670", "K833253", "K781223", "K172626", "K142784", "K844901", "K230640", "K122827", "K823343", "K920889", "K864235", "K183490", "K071572", "K031223", "K974812", "K083021", "K772284", "K932252", "K991737", "K941473", "K200109", "K883054", "K941225", "K092895", "K970463", "K897068", "K883053", "K130280", "K951247", "K031903", "K821216", "K191029", "K010443", "K082117", "K810532", "K831895", "K172984", "K910107", "K113626", "K925075", "K971877", "K132829", "K212341", "K202510", "K191444", "K203424", "K901249", "K180950", "K231652", "K050447", "K853080", "K831894", "K760824", "K130209", "K894103", "K854045", "K863515", "K151389", "K090450", "K830327", "K102464", "K781842", "K023381", "K071774", "K893207", "K802720", "K912082", "K112360", "K780078", "K873923", "K801240", "K991452", "K901250", "K933586", "K240934", "K843955", "K802970", "K961000", "K121909", "K980974", "K872107", "K901624", "K191246", "K800555", "K843956", "K073380", "K242503", "K954850", "K960074", "K162016", "K222297", "K822803", "K013915", "K894826", "K903436", "K122254", "K922933", "K862918", "K861641", "K014080", "K912078", "K211495", "K823273", "K013480", "K201642", "K153213", "K130493", "K874841", "K993772", "K082403", "K912079", "K831705", "K051997", "K172071", "K803231", "K813255", "K130333", "K953976", "K153140", "K964043", "K831122", "K926226", "K912655", "K203111", "K890808", "K923272", "K120185", "K891230", "K802719", "K931444", "K010478", "K953835", "K984271", "K833078", "K090689", "K121229", "K811004", "K895632", "K925626", "K062381", "K080708", "K100278", "K872133", "K253838", "K880021", "K922799", "K792039", "K821477", "K022450", "K140177", "K882892", "K926467", "K030264", "K180448", "K103191", "K860539", "K020351", "K093522", "K833518", "K963518", "K790356", "K231414", "K892641", "K033323", "K000255", "K973760", "K143073", "K061628", "K240666", "K130433", "K190690", "K990103", "K202206", "K961734", "K823125", "K925076", "K090511", "K901253", "K040210", "K894630", "K790406", "K102109", "K802328", "K772237", "K140181", "K892664", "K001021", "K004001", "K123314", "K013038", "K151713", "K992559", "K896978", "K934292", "K895393", "K130520", "K133261", "K150489", "K153295", "K241352", "K151791", "K842908", "K992910", "K961530", "K200683", "K141492", "K912920", "K891687", "K810505", "K043323", "K894970", "K823456" ], "registration_number": [ "3021599320", "1319639", "9617601", "3015136750", "2011171", "1625519", "3044156918", "2184009", "3030125051", "3019807891", "1218444", "9681834", "8010762", "3009507273", "3011554160", "2916596", "3014990448", "3016746283", "9680841", "1928237", "1643817", "3010155661", "3002807090", "1220648", "3005941719", "3013267343", "3008307705", "1124841", "8010026", "2528981", "3003752502", "3002806603", "3045892899", "3010163695" ], "fei_number": [ "3021599320", "1000138054", "3015136750", "2011171", "1625519", "3044156918", "3002534070", "3002807111", "3030125051", "3019807891", "1218444", "3006003617", "1000116158", "3000204839", "3009507273", "2828", "3011554160", "2916596", "3014990448", "3016746283", "1928237", "1643817", "3009649876", "3002808327", "3010155661", "1220648", "3013267343", "3008307705", "2528981", "3003752502", "3002806603", "3005426550", "3045892899", "3010163695" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }