Use caution Medical device recall · FDA · Published August 22, 2019

LivaNova SenTiva VNS Therapy Device Recall: Risk of Unintended Resets

LivaNova recalls SenTiva VNS therapy devices with serial numbers >= 100000 that may reset within 60 days, potentially requiring surgery or worsening symptoms.

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

🇺🇸 FDA recall #Z-0561-2020Medical device LivaNova ›

Use caution until it’s fixed

Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

LivaNova recalls SenTiva VNS therapy devices that could reset and become disabled within 60 days of enabling. This may require additional surgery or cause seizure/depressive symptoms to return. Read more at govinfonow.com/recall/67111-livanova-sentiva-vns-therapy-device-recall-risk-of-unintended-resets.

Source Summary by GovInfoNow · govinfonow.com/recall/67111-livanova-sentiva-vns-therapy-device-recall-risk-of-unintended-resets · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0561-2020

Cite this page

“LivaNova SenTiva VNS Therapy Device Recall: Risk of Unintended Resets.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67111-livanova-sentiva-vns-therapy-device-recall-risk-of-unintended-resets. Based on FDA recall #Z-0561-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0561-2020%22&limit=1).

The FDA announced on August 22, 2019, that LivaNova USA Inc. is recalling VNS Therapy SenTiva Model # 1000 devices due to a hazard where generators may reset and become disabled. This recall affects up to 1,687 units distributed in the U.S. and abroad.

How to tell if you have it

Brand: LivaNova
Product: VNS Therapy, SenTiva
Model #: 1000
UPC: (01)05425025750405
Serial Numbers: Greater than or equal to 100000 that did not undergo the internal error screen

The hazard

SenTiva generators may reset and become disabled within 60 days of enabling. If this occurs, patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation, potentially leading to additional surgery for premature generator replacement.

Context

GovInfoNow's records show LivaNova USA, Inc. has 18 other recalls on record since January 24, 2018. Recent similar recalls include the LivaNova SenTiva DUO VNS Therapy Generator Recall (January 3, 2025) and the LivaNova SenTiva VNS Generator Recall (December 12, 2024). Other recent recalls of similar products include the Medtronic Restore CP App Model A71100 Software Issue (November 20, 2025), the Medtronic Vanta CP App Software Recall (December 3, 2025), and the Fresenius Medical Care 5008X CAREsystem Recall (October 25, 2025).

How to tell if you have this one

Check if your SenTiva device has a serial number starting with 100000 or higher. This applies to devices that did not undergo the internal error screen.

Brand
LivaNova
Product
LivaNova USA Inc recalls VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Status
Verify if your SenTiva device has a serial number starting with 100000 or higher that did not undergo the internal error screen.

Where it went and when

Where it was distributed

Distributed in 42 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR. OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT,…” 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, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 4.6 years after the firm started it.

Aug 22, 2019Firm started the recall
Dec 20, 2019FDA classified it Class I
Jan 1, 2020Published in FDA’s Enforcement Report
Mar 28, 2024FDA terminated the recall

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

Similar recalls

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Keep exploring

More LivaNova recalls

Link to this recall

<a href="https://govinfonow.com/recall/67111-livanova-sentiva-vns-therapy-device-recall-risk-of-unintended-resets">LivaNova SenTiva VNS Therapy Device Recall: Risk of Unintended Resets (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-0561-2020 (August 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0561-2020 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.