Lower risk Medical device recall · FDA · Published September 28, 2020

LivaNova VNS Therapy AspireSR Generator recall: Serial number error causes compatibility

LivaNova recalls certain VNS Therapy AspireSR Generator devices with serial numbers containing an extra digit that may not work with software version 11.0.4. Affected units can be identified by specific serial numbers listed in the recall notice.

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

🇺🇸 FDA recall #Z-0462-2021Medical device LivaNova ›

Lower-risk recall

Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

LivaNova is recalling certain VNS Therapy AspireSR Generator devices that have an extra digit in their serial number. This makes them incompatible with therapy programmers using software version 11.0.4. If you own one of these devices, you should contact LivaNova for guidance. Read more at govinfonow.com/recall/64139-livanova-vns-therapy-aspiresr-generator-recall-serial-number-error-causes.

Source Summary by GovInfoNow · govinfonow.com/recall/64139-livanova-vns-therapy-aspiresr-generator-recall-serial-number-error-causes · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0462-2021

Cite this page

“LivaNova VNS Therapy AspireSR Generator recall: Serial number error causes compatibility.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64139-livanova-vns-therapy-aspiresr-generator-recall-serial-number-error-causes. Based on FDA recall #Z-0462-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0462-2021%22&limit=1).

The FDA announced on Sept. 28, 2020, that LivaNova USA Inc is recalling VNS Therapy AspireSR Generators because an extra digit in the serial number makes them incompatible with therapy programmers running software version 11.0.4. Owners should contact the company for assistance.

How to tell if you have it

Brand: LivaNova
Product: VNS Therapy AspireSR Generator
Model Number: 106

The hazard

The hazard stems from an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, rendering them not compatible with therapy programmers with software version 11.0.4.

Context

GovInfoNow's records show LivaNova USA, Inc. has had 18 other recalls on record since Jan. 24, 2018. Recent similar recalls include the LivaNova SenTiva DUO VNS Therapy Generator Recall on Jan. 3, 2025, and the LivaNova SenTiva VNS Generator Recall on Dec. 12, 2024. Other recent recalls of similar products include the Medtronic Restore CP App Model A71100 Software Issue on Nov. 20, 2025.

How to tell if you have this one

Check if your VNS Therapy AspireSR Generator has a serial number that appears in the list provided by LivaNova. The affected units have serial numbers with an extra digit that makes them incompatible with software version 11.0.4.

Brand
LivaNova
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Compare your device's serial number to the list of affected serial numbers provided in the recall notice.
Contact LivaNova
Reach out to LivaNova for instructions on how to proceed if your device is affected.

Where it went and when

Where it was distributed

Distributed in 27 states and D.C. and Puerto Rico.

FDA distribution: “U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, California, Colorado, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, North Carolina, Oklahoma, Oregon, Puerto Rico, Texas, Utah, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Sep 28, 2020Firm started the recall
Nov 17, 2020FDA classified it Class II
Nov 25, 2020Published in FDA’s Enforcement Report
Nov 2, 2022FDA terminated the recall

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/64139-livanova-vns-therapy-aspiresr-generator-recall-serial-number-error-causes">LivaNova VNS Therapy AspireSR Generator recall: Serial number error causes compatibility (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-0462-2021 (September 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0462-2021 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.