Recall Z-0532-2022— LivaNova USA, Inc.
Class II · Terminated
Class II FDA medical device recall by LivaNova USA, Inc., initiated 2021-12-02, terminated 2024-01-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-02
- Terminated
- 2024-01-25
- Firm location
- Houston, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.