Z-0532-2022 Class II Terminated
FDA device recall Z-0532-2022 was initiated by LivaNova USA, Inc. on December 2, 2021 and is designated Class II. 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… The recall status is terminated (terminated January 25, 2024). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 2, 2021
- Termination Date
- January 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
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.
Distribution Pattern
US: NE, MO, AR, WV, KS, MA, IN
Code Information
UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458