Lower risk Medical device recall · FDA · Published November 16, 2018

LivaNova VNS Therapy System Recall: Higher Impedance Values Risk

LivaNova recalls VNS Therapy System generators with serial numbers less than 100,000 due to higher impedance readings during diagnostics, potentially causing incorrect settings. Affected users should contact for guidance.

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

🇺🇸 FDA recall #Z-0346-2020Medical device LivaNova ›

Lower-risk recall

Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.

Take action

Contact the company

Recalling firmLivaNova USA Inc100 Cyberonics Blvd · Houston, TX 77058-2069

✎ GovInfoNow plain-language explainer

LivaNova is recalling VNS Therapy System generators with serial numbers below 100,000 because they report higher impedance values than expected during diagnostic tests. This could lead to incorrect stimulation settings, though serious injury risks are not described in the recall. Read more at govinfonow.com/recall/69459-livanova-vns-therapy-system-recall-higher-impedance-values-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69459-livanova-vns-therapy-system-recall-higher-impedance-values-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0346-2020

Cite this page

“LivaNova VNS Therapy System Recall: Higher Impedance Values Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69459-livanova-vns-therapy-system-recall-higher-impedance-values-risk. Based on FDA recall #Z-0346-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0346-2020%22&limit=1).

The FDA announced on Nov. 16, 2018, that LivaNova USA Inc. is recalling The LivaNova VNS Therapy System due to inaccurate lead impedance readings. Owners are advised to contact the company for remedy details.

How to tell if you have it

Brand: LivaNova
Product: The LivaNova VNS Therapy System
Model: Model 1000 Generator
Serial Numbers: Less than 100000

The hazard

The affected VNS generators report higher lead impedance values than previous models because of a change in measurement timing during diagnostic testing. This shift causes normal impedance ranges to fall outside the existing labeling thresholds of 600 - 5300 Ohms.

Context

GovInfoNow's records show LivaNova USA, Inc. has 18 other recalls on record since Jan. 24, 2018. Other recent recalls include a Jan. 3, 2025 recall for implanted pulse generators potentially stopping therapy and a Dec. 12, 2024 recall for SenTiva VNS Generators that may stop working.

How to tell if you have this one

Check the serial number on the generator. Affected units have serial numbers less than 100,000. The generator was approved for sale in the U.S. starting October 3, 2017.

Brand
LivaNova
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Generator Serial Number
Look for the serial number on the generator's housing; affected units have numbers below 100,000.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C., and outside the U.S.

FDA distribution: “US: PA, WV, KY, NY, MD, VA, DC, NC, GA, SC, NJ, DE, MA, OH, RI, CT, ME, NH, VT, IL, WI, IN, MO, MI, MN, SD, ND, NE,KS, IA, TX, OK, TN, MS, AL, FL, LA, ID, MT, WA, OR, UT, AK, AZ, AZ , CO, WY, NM, CA, HI, AR. Foreign (OUS): Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 12 months after the firm started it.

Nov 16, 2018Firm started the recall
Nov 7, 2019FDA classified it Class II
Nov 13, 2019Published 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/69459-livanova-vns-therapy-system-recall-higher-impedance-values-risk">LivaNova VNS Therapy System Recall: Higher Impedance Values Risk (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-0346-2020 (November 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0346-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.