LivaNova USA, Inc. Recall 89335
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)
LivaNova USA, Inc. Recall 89335 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0532-2022 |
| Event ID | 89335 |
| Event 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 Type | Devices |
| Distribution | US: NE, MO, AR, WV, KS, MA, IN |
| Quantity | 10 |
| Recall 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. |
| Device Classification | 20220209 |
| Device Code Info | UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458 |
| Center Classification Date | 20220128 |
| Recall Initiation Date | 20211202 |
| Recalling Firm | LivaNova USA, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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