FDA Device recall Z-0532-2022
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303
- FDA Device
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303 by Livanova Usa, citing 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 brea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0532-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-02 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Livanova Usa |
| Distribution | AR, IN, KS, MA, MO, NE, WV |
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.
Identifiers
| code_info | UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Livanova Usa
- SenTiva, REF: 1000
FDA Device · Class II · 2025-02-12 · Livanova Usa - SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation
FDA Device · Class II · 2025-02-12 · Livanova Usa - Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: T…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product De…
FDA Device · Class II · 2025-02-05 · Livanova Usa - VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experi…
FDA Device · Class II · 2020-12-16 · Livanova Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0532-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.