LivaNova recalls
3 official recalls and safety alerts involving LivaNova since 2022-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with LivaNova or the relevant agency.
- 2025-02-12
USLivaNova USA, Inc. recalls SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline…
FDA · DeviceLivaNova USA, Inc.US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,…Official notice →- 2025-02-05
- US
LivaNova USA, Inc. recalls Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description:…
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
FDA · DeviceLivaNova USA, Inc.Worldwide - US Nationwide distribution including in the states of AK, AZ, CA,…Official notice → - 2022-02-09
- US
LivaNova USA, Inc. recalls Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and…
A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience…