LivaNova VNS Therapy Programming System Model 3000 v1.0.2.2: Unintended Warning Message
LivaNova recalls VNS Therapy Programming System Model 3000 v1.0.2.2 due to unintended warning messages displayed on generators. Affected units have specific serial numbers and part numbers. No remedy is stated in the recall notice.
Lower-risk recall
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Contact the company
What happened, in plain English
LivaNova is recalling VNS Therapy Programming System Model 3000 version 1.0.2.2 because it displays unintended warning messages. This recall affects specific units with unique serial numbers and part numbers. The issue does not pose a direct safety risk but requires attention to prevent potential confusion in medical device programming. Read more at govinfonow.com/recall/72103-livanova-vns-therapy-programming-system-model-3000-v1-0-2.
Source Summary by GovInfoNow · govinfonow.com/recall/72103-livanova-vns-therapy-programming-system-model-3000-v1-0-2 · Updated August 31, 2026 · FDA enforcement record: FDA #Z-2572-2018
Cite this page
“LivaNova VNS Therapy Programming System Model 3000 v1.0.2.2: Unintended Warning Message.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72103-livanova-vns-therapy-programming-system-model-3000-v1-0-2. Based on FDA recall #Z-2572-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2572-2018%22&limit=1).
Why it’s dangerous
The VNS Therapy Programming System Model 3000 v1.0.2.2 displays unintended warning messages on the device's generators. This could lead to confusion during programming sessions but does not cause physical injury or damage to the patient.
Who’s affected
Medical professionals who use this VNS therapy programming system for patients with vagus nerve stimulation implants. The risk is low as the issue involves unintended warning messages rather than physical harm.
How to tell if you have this one
Check for the model number '3000' and version 'v1.0.2.2' on the device. Affected units have specific serial numbers and part numbers listed in the recall notice, including the UDI numbers starting with FMT77F2, FKR57F2, FCR77F2, etc.
- Brand
LivaNova- Category
Medical device
What to do — step by step
Check Device Version
Verify the device version by checking the model number and version on the VNS Therapy Programming System. If it matches Model 3000 v1.0.2.2, it is affected.
Where it went and when
Where it was distributed
Distributed in 16 states.
FDA distribution: “Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Georgia, Illinois, Indiana, Iowa, Missouri, Montana, New York, North Carolina, Pennsylvania, South Dakota, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 5.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-2572-2018 (January 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2572-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 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.