Lower riskMedical device recall · FDA · Published August 13, 2019
LivaNova VNS Therapy SENTIVA Generator Model 1000: Sterilization Issue
LivaNova recalls VNS Therapy SENTIVA Generator Model 1000 units that were sterilized with an extra cycle, which may not meet quality standards. Affected units have specific model labels and serial numbers.
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
Take action
Contact the company
📍Recalling firmLivaNova USA Inc100 Cyberonics Blvd · Houston, TX 77058-2069
“LivaNova VNS Therapy SENTIVA Generator Model 1000: Sterilization Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67225-livanova-vns-therapy-sentiva-generator-model-1000-sterilization-issue. Based on FDA recall #Z-1118-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2020%22&limit=1).
LivaNova USA Inc recalled VNS Therapy SENTIVA Generators on Aug. 13, 2019, after FDA records show they were sterilized one additional cycle, failing quality specifications. The Food and Drug Administration announced the Class II voluntary recall of six units distributed in Florida, Georgia, Kansas, Missouri, and Utah.
How to tell if you have it
Brand: LivaNova
Product: VNS Therapy SENTIVA Generator Model # 1000
Labeling: 26-0009-6800
Sample Labels: 26-0009-9600
Serial Nos.: 204460, 183960, 194980, 204700, 206720, 213290
The hazard
The firm identified that a subset of its generators underwent an additional sterilization cycle that does not meet the firm's quality specifications. The record provides no information on incidents or injuries associated with this hazard.
Context
GovInfoNow's records show LivaNova USA, Inc. has 18 other recalls on record since Jan. 24, 2018. Other recent recalls of similar products include a potential therapy delivery stoppage (Jan. 3, 2025), VNS generators stopping work with seizure return risk (Dec. 12, 2024), and lead breach risks (Dec. 2, 2021). Recent recalls of similar products include Maquet Vasoview Hemopro 2 gamma sterilization issues (June 2, 2026) and Medline Convenience Kits sterility risk from calibration issues (Jan. 7, 2026).
How to tell if you have this one
Check for model labels with 'Model 1000' and serial numbers starting with 204460, 183960, 194980, 204700, 206720, or 213290. The units were sold with specific labeling codes like 26-0009-6800 or 26-0009-9600.
Brand
LivaNova
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Label
Look for model labels with 'Model 1000' and serial numbers starting with 204460, 183960, 194980, 204700, 206720, or 213290.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “US: FL, GA, KS, MO, and UT. No OUS distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Georgia, Kansas, Missouri, Utah.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1118-2020 (August 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1118-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.