Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vagus Nerve Stimulation (VNS) Therapy Leads Recalled by LivaNova USA, Inc. Due to A manufacturing issue may cause the silicone tubing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova USA, Inc. directly.
Affected Products
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
Quantity: 10
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 7 states: AR, IN, KS, MA, MO, NE, WV
About LivaNova USA, Inc.
LivaNova USA, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report