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)
Check against the official notice below — it lists the full affected range.
LivaNova USA, Inc. is recalling vagus nerve stimulation (VNS) therapy leads, specifically Model 303-20 and Model 303-30 PerenniaDURA Leads. A manufacturing defect may have caused the silicone tubing wall thickness to be thinner than the design specification. If this tubing becomes completely breached, patients could experience discomfort or pain from stimulation delivered to unintended locations. Additionally, if the inner lead conductor is exposed to body fluids, the lead may break and cause loss of therapy.
The recall affects 10 devices distributed across Nebraska, Missouri, Arkansas, West Virginia, Kansas, Massachusetts, and Indiana. The affected leads have UDI 05425025750115 and serial numbers 119441 through 119458. The source does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US: NE, MO, AR, WV, KS, MA, IN Quantity: 10 Lot/code info: UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.