Vagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect
LivaNova's PerenniaDURA vagus nerve stimulation leads may have insufficient silicone tubing thickness due to a manufacturing issue. This could result in unintended stimulation delivery or loss of therapy if the tubing is breached.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a risk-of-harm medical device (FDA Class II) with no reported illnesses or injuries. The manufacturing defect could result in loss of therapy or unintended electrical stimulation, meeting the High severity criteria for theoretical hazards without yet-reported patient harm.
Plain-English summary
LivaNova USA, Inc. is recalling 10 units of PerenniaDURA vagus nerve stimulation (VNS) therapy leads, Model 303, due to a manufacturing issue. The affected units have serial numbers 119441 through 119458.
A manufacturing defect may cause the silicone tubing wall thickness to be less than the design specification. If the tubing becomes completely breached, the inner lead conductor may be exposed to body fluids, potentially causing the lead to break and result in loss of therapy. Patients may experience discomfort or pain if stimulation is delivered to an unintended location.
The recalled units were distributed to medical facilities in the United States. Patients who believe they may have received one of these leads should contact their healthcare provider to determine if their specific device is affected and to discuss appropriate monitoring or follow-up care.
The recalled product
- 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)
- Manufacturer
- LivaNova USA, Inc.
- Hazard
- lead-breakage
- unintended-stimulation
- loss-of-therapy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- UDI: 05425025750115. Serial Numbers: 119441
- 119442
- 119443
- 119452
- 119453
- 119454
- 119455
- 119456
- 119457
- 119458
Distribution
Distributed in 7 states:
- AR
- IN
- KS
- MA
- MO
- NE
- WV
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