Lower riskMedical device recall · FDA · Published December 2, 2021
LivaNova VNS Therapy Leads Model 303 Recall: Risk of Lead Breach
LivaNova recalls VNS therapy leads model 303 due to potential silicone tubing wall thickness issues that could cause lead breach and discomfort or loss of therapy.
A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.
Take action
Contact the company
📍Recalling firmLivaNova USA, Inc.100 Cyberonics Blvd · Houston, TX 77058-2069
✎ GovInfoNow plain-language explainer
LivaNova is recalling VNS therapy leads model 303 and 303-20/30 due to a possible manufacturing defect that might cause the silicone tubing to be too thin. This could lead to the lead breaking or causing discomfort if the inner conductor is exposed to body fluids. Read more at govinfonow.com/recall/61476-livanova-vns-therapy-leads-model-303-recall-risk-of-lead.
“LivaNova VNS Therapy Leads Model 303 Recall: Risk of Lead Breach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61476-livanova-vns-therapy-leads-model-303-recall-risk-of-lead. Based on FDA recall #Z-0532-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0532-2022%22&limit=1).
LivaNova USA, Inc. recalled Vagus Nerve Stimulation Therapy Leads on Dec. 2, 2021, according to the FDA. The agency announced the voluntary Class II recall due to a manufacturing issue that may cause lead breakage or unintended stimulation.
A manufacturing issue may cause the silicone tubing wall thickness to be less than design specifications. If the tubing breaches, patients may experience discomfort or pain from unintended stimulation. Exposure of the inner lead conductor to body fluids may cause the lead to break, resulting in loss of therapy.
Context
GovInfoNow's records show LivaNova USA, Inc. has had 18 other recalls since Jan. 24, 2018. Recent similar recalls include the SenTiva DUO VNS Therapy Generator recall on Jan. 3, 2025, and the SenTiva VNS Generator recall on Dec. 12, 2024. Other recent recalls of similar products include the Boston Scientific INFINION CX Lead Kits Recall (June 17, 2026) and the Medtronic DLP Cannula Recall (April 21, 2026).
How to tell if you have this one
Check for the model numbers 303, 303-20, or 303-30 on the leads. Look for the specific serial numbers listed: 119441 through 119458.
Brand
LivaNova
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Verify if your leads have serial numbers 119441 through 119458.
Where it went and when
Where it was distributed
Distributed in 7 states.
Listed by the agency
Not listed
FDA distribution: “US: NE, MO, AR, WV, KS, MA, IN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, Indiana, Kansas, Massachusetts, Missouri, Nebraska, West Virginia.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0532-2022 (December 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0532-2022 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.