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.
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.
The silicone tubing may be thinner than designed, which could lead to the tubing becoming completely breached. If this happens, the lead might deliver stimulation to an unintended location causing discomfort or pain. If the inner conductor is exposed to body fluids, the lead could break, resulting in loss of therapy.
Patients using LivaNova VNS therapy leads model 303, 303-20, or 303-30 are affected. Those with the specific serial numbers listed are most at risk.
Check for the model numbers 303, 303-20, or 303-30 on the leads. Look for the specific serial numbers listed: 119441 through 119458.
Verify if your leads have serial numbers 119441 through 119458.
Model 303, 303-20, and 303-30 PereniaDURA leads with specific serial numbers.
The leads might become breached, causing discomfort or pain, or the inner conductor could break if exposed to body fluids, leading to loss of therapy.
Check for the model numbers 303, 303-20, or 303-30 and the specific serial numbers 119441 through 119458.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0532-2022 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0532-2022 from LivaNova. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
