Use caution Medical device recall · FDA · Published December 12, 2024

LivaNova SenTiva VNS Generators May Stop Working; Risk of Seizure Return

LivaNova recalls SenTiva and SenTiva Duo vagus nerve stimulator generators with serial numbers under 500,000 that may stop delivering therapy, risking seizure return or surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1072-2025Medical device LivaNova ›

Use caution until it’s fixed

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 seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

Take action

Contact the company

Recalling firmLivaNova USA, Inc.100 Cyberonics Blvd · Houston, TX 77058-2069

✎ GovInfoNow plain-language explainer

LivaNova recalls SenTiva and SenTiva Duo vagus nerve stimulator generators with serial numbers under 500,000. These devices may stop delivering therapy, causing patients to return to seizure frequency or depressive symptoms and potentially requiring surgery. Read more at govinfonow.com/recall/53303-livanova-sentiva-vns-generators-may-stop-working-risk-of-seizure.

Source Summary by GovInfoNow · govinfonow.com/recall/53303-livanova-sentiva-vns-generators-may-stop-working-risk-of-seizure · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1072-2025

Cite this page

“LivaNova SenTiva VNS Generators May Stop Working; Risk of Seizure Return.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53303-livanova-sentiva-vns-generators-may-stop-working-risk-of-seizure. Based on FDA recall #Z-1072-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1072-2025%22&limit=1).

The FDA announced on Dec. 12, 2024, that LivaNova USA, Inc. is recalling SenTiva and SenTiva Duo generators for the VNS Therapy System due to a hazard of stopping stimulation delivery. The agency issued recall number Z-1072-2025 for the voluntary Class II action.

How to tell if you have it

Brand: LivaNova
Product: SenTiva, REF: 1000
Product: SenTiva Duo, REF: 1000-D
Serial Numbers less than 500,000

The hazard

Vagus nerve stimulator generators may stop delivering stimulation because an internal, mechanically activated component can become stuck in a closed position. This failure may cause patients to return to baseline seizure frequency or depressive symptoms and potentially require generator replacement surgery.

Context

GovInfoNow's records show LivaNova USA, Inc. has 18 other recalls on record since Jan. 24, 2018. On Jan. 3, 2025, the company recalled implanted pulse generators due to a potential that they may stop delivering therapy because of an internal component issue. Other recent recalls include the Dec. 2, 2021, recall of VNS Therapy Leads Model 303 for risk of lead breach and the Nov. 12, 2020, recall of the SENTIVA DUO Device showing a wrong model number after reset.

How to tell if you have this one

Check the serial number on your generator. The recalled units have serial numbers less than 500,000. These devices are part of the VNS therapy system for vagus nerve stimulation.

Brand
LivaNova
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT. OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA.

Recall number	Product, codes & lots	Quantity
Z-1072-2025	SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).; REF/UDI-DI: 1000/05425025750405, 1000-D/05425025750528 All Serial Numbers less than 500,000	81,606
Z-1073-2025	SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).; UDI-DI: 05425025750405. All Serial Numbers less than 500,000.	48

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial number on your generator; recalled units have numbers less than 500,000.
Contact Manufacturer
Reach out to LivaNova for guidance on next steps if your device is affected.

Where it went and when

Where it was distributed

Distributed in 39 states.

FDA distribution: “US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT. OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Dec 12, 2024Firm started the recall
Jan 31, 2025FDA classified it Class II
Feb 12, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53303-livanova-sentiva-vns-generators-may-stop-working-risk-of-seizure">LivaNova SenTiva VNS Generators May Stop Working; Risk of Seizure Return (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1072-2025 (December 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1072-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.