Livanova Usa, Inc.
Houston, TX
This page shows every FDA and USDA recall linked to Livanova Usa, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
15
Total Recalls
2018
First Recall
2025
Most Recent
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System.
Used for Vagus Nerve...
Jan 31, 2025
· Device
Open, Classified
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation.
Used for Vagus Ner...
Jan 31, 2025
· Device
Open, Classified
Brand Name: SenTiva DUO"
Product Name: VNS Therapy SenTiva DUO", Model 1000-D
Model/Catalog Number: 1000-D
Sof...
Jan 30, 2025
· Device
Open, Classified
Brand Name: SenTiva"
Product Name: VNS Therapy" SenTiva", Model 1000
Model/Catalog Number: 1000
Software Versi...
Jan 30, 2025
· Device
Open, Classified
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm...
Dec 2, 2021
· Device
Terminated
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depressi...
Nov 12, 2020
· Device
Terminated
VNS Therapy AspireSR Generator
Sep 28, 2020
· Device
Terminated
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
Feb 4, 2020
· Device
Open, Classified
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Dec 20, 2019
· Device
Terminated
VNS Therapy SENTIVA Generator Model # 1000
Labeling
26-0009-6800 Model 1000 Generator Sample Labels
26-0009-...
Aug 13, 2019
· Device
Terminated
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONI...
Nov 16, 2018
· Device
Terminated
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therap...
Nov 16, 2018
· Device
Open, Classified
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONIC...
Nov 16, 2018
· Device
Terminated
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Nov 16, 2018
· Device
Open, Classified
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Jan 24, 2018
· Device
Terminated