{ "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": "2026-10-08", "results": { "skip": 0, "limit": 1, "total": 49 } }, "results": [ { "cfres_id": "222528", "product_res_number": "Z-0088-2027", "event_date_initiated": "2026-08-20", "event_date_posted": "2026-10-05", "recall_status": "Open, Classified", "res_event_number": "99818", "product_code": "QFG", "k_numbers": [ "K253743" ], "product_description": "Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery. The primary user interface and primary display for the MiniMed Flex pump is the MiniMed app, also the user interface for the compatible MiniMed iAGCs, which runs on a compatible iOS or Android device.", "code_info": "MMT-8072\nLot Code: Serial numbers: FB00015839, FB00016511, FB00014455, FB00011553, FB00015700, FB00011357, FB00019307, FB00014766, FB00014822, FB00015828, FB00018580, FB00010465, FB00014472, FB00015793, FB00015794, FB00015796, FB00015799, FB00015801, FB00015977, FB00017271.\n\nUDI-DI/GTIN: 00763000848156\n\nNote: Initially 25 pumps were identified as put into service, however 2 were shipped to Marketing Team Members and recovered. 3 Pumps were returned through complaint process. Final total of pumps available in the field is 20.\n\nMMT-8062\nLot Code: Serial numbers: FB00011770, FB00015162, FB00016429, FB00014760, \nFB00015797\n\nUDI-DI/GTIN: 00763000848149\n\n(Serial Numbers: FB00017271, FB00011770, FB00015162, FB00016429, FB00014760 were returned via complaint process or shipped to Marketing Team Members).", "firm_fei_number": "3003166194", "recalling_firm": "Medtronic MiniMed, Inc.", "address_1": "18000 Devonshire St", "city": "Northridge", "state": "CA", "postal_code": "91325-1219", "additional_info_contact": "Ashley Patterson\n800-6464633", "reason_for_recall": "Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery charging, disconnection issues with other system components (i.e., continuous glucose monitoring sensor or MiniMed mobile app), reduced ability to detect occlusion events, compromised audio for pump alarms/alerts, and/or inaccurate insulin delivery.", "root_cause_description": "Under Investigation by firm", "action": "On 08/20/2026, Technical Support called affected customers to inform that, MiniMed identified an issue in which certain MiniMed Flex Insulin Pumps (MMT-8062) were released to customers with incomplete manufacturing testing. As a result of incomplete testing, your pump may have the potential for lack of protection from moisture exposure, slow charging, disconnection with sensor or MiniMed App, reduced ability to detect occlusion, no audio or low audio volume for alarms/alerts, or insulin under-delivery. If your pump experiences these issues, it could potentially lead to delayed therapy or risk of hypoglycemia, hyperglycemia, diabetic ketoacidosis (DKA) or death.\n\nFor customers that were not able to be contacted via telephone call, an \"URGENT MEDICAL DEVICE RECALL\" Letter will be sent viaUSPS First-Class Mail. \n\nCustomers are instructed to:\n1. Stop using the Flex pump in their possession and revert to their back-up plan for insulin therapy.\n2. Contact MiniMed immediately at (844) 885-0259 so arrangement can be made to ship customers a new Flex pump overnight. Upon calling, please say Flex when prompted to connect with an agent.\n3. Please acknowledge that you ve read and understood this notification and have followed the actions listed by completing and returning the confirmation form, scanning the QR code below with your phone or tablet, or by visiting [https://www.minimed.com/en-us/safety-notices/notice33-letter] to acknowledge communication.\n\nFor Questions or assistance - call the MiniMed 24-Hour Technical Support line at 1-800-646-4633, option 1.", "product_quantity": "25", "distribution_pattern": "U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI, MN, NJ, NY, OH, PA, SD, TN, TX, and WV.", "openfda": { "k_number": [ "K233952", "K251032", "K213134", "K201214", "K223213", "K253470", "K240309", "K241178", "K232380", "K234027", "K253743", "K231826", "K260001", "K261672", "K233044", "K203234", "K223846", "K253074", "K231485", "DEN180058", "K213536", "K230545", "K253976", "K191679", "K241078", "K250792", "K203768", "K252770", "K250930" ], "registration_number": [ "2024024", "2029275", "3008824097", "2032098", "2246552", "3016540876", "2032227", "3019807891", "3007981285", "3047799708", "3030970576", "3016798778", "1220973", "3044561902", "1220477", "3005627859", "3015192982", "3016245399", "3042027705", "2030624", "3014197758", "2030598", "3014585508", "3032746481", "3010291427", "3019004087", "2022435", "3013756811", "3026266833" ], "fei_number": [ "2024024", "3008824097", "2246552", "3016540876", "3019807891", "3003166194", "1000518731", "3007981285", "1000306431", "3047799708", "3030970576", "3016798778", "1220973", "3044561902", "3003058448", "1220477", "3005627859", "3015192982", "3016245399", "3042027705", "3014197758", "3014585508", "3032746481", "3000206435", "3010291427", "3019004087", "2022435", "3013756811", "3026266833" ], "device_name": "Alternate Controller Enabled Insulin Infusion Pump", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "880.5730", "device_class": "2" } } ] }