LivaNova VNS Therapy Program GMDN 3000 V1.5.2: False High Impedance Risk
LivaNova recalls VNS Therapy Program GMDN 3000 V1.5.2 software version devices that may display false high impedance values during patient follow-up due to a diagnostic test error.
Lower-risk recall
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
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What happened, in plain English
LivaNova is recalling VNS Therapy Program GMDN devices with software version 1.5.2 that may incorrectly perform a diagnostic test, causing false high impedance readings during patient follow-ups. This could lead to inaccurate treatment adjustments. Read more at govinfonow.com/recall/69458-livanova-vns-therapy-program-gmdn-3000-v1-5-2-false.
Source Summary by GovInfoNow · govinfonow.com/recall/69458-livanova-vns-therapy-program-gmdn-3000-v1-5-2-false · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0663-2020
Cite this page
“LivaNova VNS Therapy Program GMDN 3000 V1.5.2: False High Impedance Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/69458-livanova-vns-therapy-program-gmdn-3000-v1-5-2-false. Based on FDA recall #Z-0663-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0663-2020%22&limit=1).
Why it’s dangerous
The device may errantly perform a normal mode diagnostic test instead of the selected system diagnostic test when output current exceeds 0.5mA. This causes false high impedance values during patient follow-up, potentially leading to inaccurate treatment adjustments.
Who’s affected
Patients using VNS therapy devices with software version 1.5.2 (Model # 3000) are affected. The risk is low as the issue only affects diagnostic readings, not patient safety.
How to tell if you have this one
Check for software version 1.5.2 on your VNS Therapy Program GMDN device (Model # 3000). The recall includes specific serial numbers and UDI numbers listed in the record.
- Brand
LivaNova- Category
Medical device
What to do — step by step
Check Software Version
Verify your device's software version by checking the device settings or documentation. The affected version is 1.5.2.
Where it went and when
Where it was distributed
Distributed in 46 states and D.C..
FDA distribution: “IL, AK, AL, AR, AZ, CA, CA , CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD MI, MN, MO, MS, MT, NC, ND, NE, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WA , WI, WV, WY,” 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, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0663-2020 (November 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0663-2020 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.