Filing Flows › LivaNova (LIVN) › Recalls, complaints & regulation
LivaNova (LIVN): recalls, EPA violations and clinical trials
LivaNova (LIVN) beyond its filings: 0 recalls in the last 12 months (8 in five years, 0 Class I); 0 EPA-regulated facilities in violation, $7K in penalties over five years; 2 active clinical trials.
Latest recalls
- 2025-02-12 · FDA device · SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
- 2025-02-12 · FDA device · SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
- 2025-02-05 · FDA device · Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS T
- 2025-02-05 · FDA device · Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The Li
- 2024-12-04 · FDA device · Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
- 2023-10-18 · FDA device · 3T Heater Cooler System, REF: 16-02-85
- 2022-03-23 · FDA device · Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypa
- 2022-02-09 · FDA device · Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 Pereni
LivaNova's latest quarter
LivaNova, Q3 2026: revenue $393M (+10% year over year), operating margin 7.2%, net earnings $34.3M, operating cash flow $73.7M. The chart follows the revenue to costs, profit and cash.
Questions
Has LivaNova had any recalls?
8 recalls on file over five years from the FDA, CPSC and NHTSA; 0 in the last 12 months.
Has LivaNova been fined by the EPA?
The 1 EPA-regulated facility on file under its name drew $7K in penalties over five years; 0 are in violation now.
How many clinical trials does LivaNova have?
2 active studies on ClinicalTrials.gov, 0 in phase 3.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.