{"recall":{"id":"fda-device-99844","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Abbott recalls Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1","firm":"Abbott","date":"2026-09-10","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8. 9-ACP2-010-034","code":"UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.","quantity":"","number":"Z-0191-2027","classification":"Class II"}],"reason":"Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution.","nationwide":true,"states":[],"units":"","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=99844","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5161f3ba095d1063","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=99844","record":[{"status":"Ongoing","city":"Plymouth","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99844","recalling_firm":"Abbott","address_1":"5050 Nathan Ln N","address_2":"","postal_code":"55442-3209","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0191-2027","product_description":"Amplatzer Amulet Left Atrial Appendage Occluder    Model Numbers  1. 9-ACP2-007-016  2. 9-ACP2-007-018  3. 9-ACP2-007-020  4. 9-ACP2-007-022  5. 9-ACP2-010-025  6. 9-ACP2-010-028  7. 9-ACP2-010-031  8. 9-ACP2-010-034","product_quantity":"","reason_for_recall":"Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).","recall_initiation_date":"20260910","center_classification_date":"20261016","report_date":"20261028","code_info":"UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527  All lots/serial numbers.","more_code_info":""}]}}