{"id":"2d33f35b-e224-4554-a1c1-ae83f81eb292","slug":"fda-recall-intuitive-ion-catheter-2020","filingNumber":"Z-0489-2021","filingType":"fda_recall","jurisdiction":"us_fda","applicantCompanyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","filingDate":"2020-10-23T12:00:00.000Z","decisionDate":"2020-12-02T12:00:00.000Z","status":"recalled","clearanceScope":"Intuitive Ion Endoluminal System fully-articulating catheter (REF 490105): distal tip ring may become dislodged during the procedure. FDA Class II.","sources":[{"url":"https://api.fda.gov/device/enforcement.json?search=recall_number:Z-0489-2021","title":"FDA recall Z-0489-2021","sourceName":"openFDA (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":"985cc77b-b062-41c9-8f0e-f2c436c2b64f","reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-05T18:22:51.374Z","updatedAt":"2026-06-05T18:22:51.374Z","applicantCompany":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","slug":"intuitive-surgical","name":"Intuitive Surgical"},"modelLinks":[{"id":"ba18aeba-cf2f-48bc-9abb-8e1c9c337a03","modelId":"0e2f5d6f-8ce6-4726-9301-d438ecf732bc","regulatoryFilingId":"2d33f35b-e224-4554-a1c1-ae83f81eb292","createdAt":"2026-06-05T18:22:51.533Z","model":{"slug":"intuitive-ion","modelName":"Ion Endoluminal System"}}]}