CLASS II Device recall · Reported 9 Feb 2022 · FDA Enforcement Report
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA recalled
LivaNova USA is recalling Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, distributed in 7 states. The recall was initiated on 2 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0532-2022
- FDA event ID
- 89335
- Recalling firm
- LivaNova USA, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2021
- FDA classified
- 28 Jan 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 Dec 2021 | Recall initiated by company | |
| 28 Jan 2022 | Classified by FDA | +57 days |
| 9 Feb 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
US: NE, MO, AR, WV, KS, MA, IN
ArkansasIndianaKansasMassachusettsMissouriNebraskaWest Virginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458
Where was it sold?
US: NE, MO, AR, WV, KS, MA, IN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LivaNova USA
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | VNS Therapy¿ SenTiva DUO" recalled by LivaNova USA | LivaNova USA | Packaging Defects | Nationwide |
| Device | CLASS II | VNS Therapy Sentiva DUO # 1000-D recalled by LivaNova USA | LivaNova USA | Other | TX |
| Device | CLASS II | VNS Therapy¿ AspireSR¿ Generator recalled by LivaNova USA | LivaNova USA | Device Malfunction | 29 states |
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