{"recall":{"id":"fda-device-99765","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medtronic MiniMed, Inc. recalls CareLink Clinic","firm":"Medtronic MiniMed, Inc.","date":"2026-09-11","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"CareLink Clinic, REF: MMT-7350","code":"UDI-DI: 0763000B00008748K. Software Versions: 4.4A Software Available: US: Between June 4th, 2026, and June 8th, 2026.","quantity":"1","number":"Z-0203-2027","classification":"Class II"}],"reason":"CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the system-recommended values, resulting in incorrect rapid-acting insulin parameters. If an HCP or patient inputs these incorrect setting values into the patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their insulin needs, potentially leading to over/under delivery of insulin with a severity ranging from Catastrophic (death from severe hypoglycemia) to Minor (self-treatable hypoglycemia/hyperglycemia).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of KS.","nationwide":true,"states":[],"units":"1","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99765","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"6061798d8b30075b","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99765","record":[{"status":"Ongoing","city":"Northridge","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99765","recalling_firm":"Medtronic MiniMed, Inc.","address_1":"18000 Devonshire St","address_2":"","postal_code":"91325-1219","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the state of KS.","recall_number":"Z-0203-2027","product_description":"CareLink Clinic, REF: MMT-7350","product_quantity":"1","reason_for_recall":"CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the system-recommended values, resulting in incorrect rapid-acting insulin parameters. If an HCP or patient inputs these incorrect setting values into the patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their insulin needs, potentially leading to over/under delivery of insulin with a severity ranging from Catastrophic (death from severe hypoglycemia) to Minor (self-treatable hypoglycemia/hyperglycemia).","recall_initiation_date":"20260911","center_classification_date":"20261021","report_date":"20261028","code_info":"UDI-DI: 0763000B00008748K.  Software Versions: 4.4A  Software Available: US: Between June 4th, 2026, and June 8th, 2026.","more_code_info":""}]}}