Recall Z-0532-2022 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA, Inc.
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)
| Date | Dec 2, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | On 12/02/21, Liva Nova initiated a verbal notification to hospital consignees. Hospitals were asked to remove affected devices from inventory. On 12/17/21, a removal notice was distributed to consignees who were asked to take the following actions: 1. Remove affected devices from your hospital/facility s inventory. 2. Recalling firm will contact you to coordinate removal and replacement of these devices. 4. If affected devices have been implanted, please notify your local representative as soon as possible. A medical device correction notice was sent to doctors managing patients with implant |
| Quantity | 10 |
| Distribution | US: NE, MO, AR, WV, KS, MA, IN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.