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Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA...

FDA Recall #Z-0532-2022 — Class II — December 2, 2021

Recall #Z-0532-2022 Date: December 2, 2021 Classification: Class II Status: Terminated

Product Description

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)

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.

Recalling Firm

LivaNova USA, Inc. — Houston, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

10

Distribution

US: NE, MO, AR, WV, KS, MA, IN

Code Information

UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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