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LivaNova USA, Inc. FDA Recalls
5 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Class IIJan 3, 2025Their is a potential that implanted pulse generators may sto |
| Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Class IIJan 3, 2025Their is a potential that implanted pulse generators may sto |
| SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve StimulaClass IIDec 12, 2024Vagus nerve stimulator generators may stop delivering stimul |
| SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve StimulClass IIDec 12, 2024Vagus nerve stimulator generators may stop delivering stimul |
| Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrodeClass IIDec 2, 2021A manufacturing issue may cause the silicone tubing wall thi |