Reported Feb 9, 2022 · Terminated
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode…
LivaNova USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova USA, Inc. · 100 Cyberonics Blvd · Houston, TX · 77058-2069
Is this the product you have?
- Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA
- Model303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
- Lot codes and dates
- UDI05425025750115
- Serial Numbers
119441119442119443119452119453119454119455119456119457119458
- Amount recalled
- 10
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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