Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 9, 2022
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)
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
LivaNova USA, Inc. recalled Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 Per… - a moderate-severity action.
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 Per… was recalled by LivaNova USA, Inc. in February 9, 2022. Reason: A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be les…. Check the official notice for the remedy. Verify recall #Z-0532-2022 with the FDA Devices before acting.
The recall
LivaNova USA, Inc. issued this moderate-severity FDA Devices recall-A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be les….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- February 9, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0532-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0532-2022) was formally reported on February 9, 2022, with the manufacturer initiating the action on December 2, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. LivaNova USA, Inc. is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 10.
The documented reason for this recall is: 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 discomf… Distribution data in the federal record shows the product reached: US: NE, MO, AR, WV, KS, MA, IN. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
3 from same agency
Product 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)
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0532-2022 |
| Date reported | February 9, 2022 |
| Date initiated | December 2, 2021 |
| Recalling firm | LivaNova USA, Inc. |
| Firm location | Houston, TX |
| Affected scope | 10 |
| Distribution | US: NE, MO, AR, WV, KS, MA, IN |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0532-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by LivaNova USA, Inc.. Units affected: 10.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 9, 2022. Severity: Moderate. Recall number: Z-0532-2022.
Where was the recalled product distributed? ▼
Distribution: US: NE, MO, AR, WV, KS, MA, IN.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0532-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 9, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.