FDA-Device2022-02-09Class II
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)
LivaNova USA, Inc.
Hazard
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.
Sold states
US: NE, MO, AR, WV, KS, MA, IN
Affected count
10
Manufactured in
100 Cyberonics Blvd, N/A, Houston, TX, United States
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2022Don't want to check this manually?
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