LivaNova USA, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0532-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: December 2, 2021

Date Posted: February 9, 2022

Recall Number: Z-0532-2022

Event ID: 89335

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.

Status: Terminated

Product Quantity: 10

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated