Lower risk Medical device recall · FDA · Published February 4, 2020

LivaNova VNS Programmer Model 3000 Recall: False Positive Warnings Risk Medical

LivaNova recalls VNS Therapy Programmer Model 3000 (v1.6) used with specific VNS generators due to false positive warnings that may cause unnecessary medical procedures. Affected users should contact LivaNova for guidance.

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

🇺🇸 FDA recall #Z-1563-2020Medical device LivaNova ›

Lower-risk recall

False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

LivaNova is recalling its VNS Therapy Programmer Model 3000 (version 1.6) that works with certain VNS generators. False positive warnings could lead users to believe the device is malfunctioning, potentially causing unnecessary medical interventions. Read more at govinfonow.com/recall/65901-livanova-vns-programmer-model-3000-recall-false-positive-warnings-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65901-livanova-vns-programmer-model-3000-recall-false-positive-warnings-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1563-2020

Cite this page

“LivaNova VNS Programmer Model 3000 Recall: False Positive Warnings Risk Medical.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65901-livanova-vns-programmer-model-3000-recall-false-positive-warnings-risk. Based on FDA recall #Z-1563-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1563-2020%22&limit=1).

The FDA announced on Feb. 4, 2020, that LivaNova USA Inc. is recalling the VNS Therapy Programmer, Model 3000, version 1.6. The device may issue false positive warnings, potentially leading to unnecessary medical or surgical intervention.

How to tell if you have it

LivaNova VNS Therapy Programmer, Model 3000, version 1.6
Used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators

The hazard

According to the FDA, a false positive warning may occur after interrogating the generator at 0mA normal output current, programming it to non-0mA output current, or performing an in-session re-interrogation. Users are instructed to lower the output current and widen the pulse width, as only system diagnostic testing evaluates output current. The agency noted that users may conclude there is a device malfunction, which could lead to medical or surgical intervention.

Context

GovInfoNow's records show LivaNova USA, Inc. has had 18 other recalls on record since Jan. 24, 2018. Other recent recalls of similar products include LivaNova SenTiva DUO VNS Therapy Generator Recall (Jan. 3, 2025), LivaNova SenTiva VNS Generator Recall (Dec. 12, 2024), and LivaNova VNS Therapy Leads Model 303 Recall (Dec. 2, 2021). Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (May 6, 2026) and Edan iM20 Patient Monitor Recall (Oct. 24, 2025).

How to tell if you have this one

Check for the VNS Therapy Programmer Model 3000 with version 1.6. The device is used with VNS generators models 103, 104, 105, 106, or 8103.

Brand
LivaNova
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact LivaNova
Reach out to LivaNova for guidance on whether your device is affected and next steps.

Where it went and when

Where it was distributed

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

FDA distribution: “U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT. Canada, and Israel.” 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, Nevada, 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 57 days after the firm started it.

Feb 4, 2020Firm started the recall
Mar 24, 2020FDA classified it Class II
Apr 1, 2020Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More LivaNova recalls

Link to this recall

<a href="https://govinfonow.com/recall/65901-livanova-vns-programmer-model-3000-recall-false-positive-warnings-risk">LivaNova VNS Programmer Model 3000 Recall: False Positive Warnings Risk Medical (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-1563-2020 (February 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1563-2020 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.