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LivaNova USA, Inc.

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. U recall (Z-1072-2025)LivaNova USA, Inc.2025-01-31
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation recall (Z-1073-2025)LivaNova USA, Inc.2025-01-31
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: recall (Z-1067-2025)LivaNova USA, Inc.2025-01-30
Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D Model/Catalo recall (Z-1068-2025)LivaNova USA, Inc.2025-01-30
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulatio recall (Z-0561-2020)LivaNova USA Inc2019-12-20

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