Z-0532-2022Class II

Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm...

Name: Z-0532-2022 Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm...
Creator: LivaNova USA, Inc.
Published: 2021-12-02
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2021-12-02 / Terminated / root cause: manufacturing process

FDA source

LivaNova USA, Inc. began a recall of Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30... on 2021-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0532-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-02
Posted: 2022-01-28
Terminated: 2024-01-25
Recalling firm: LivaNova USA, Inc.
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)
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
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.
Root cause tag: manufacturing process
FDA 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 implanted affected devices were asked to take the following actions: 1. Ask the patient to report any changes in the comfort or perception of their stimulation therapy. 2. Advise patients to use their magnet daily (epilepsy indication only) to verify that stimulation is felt, and to report any change in perceived clinical symptoms related to stimulation. An inability to feel stimulation or changes in clinical symptoms may be an early indicator of a lead break (e.g., increase in seizures, painful stimulation, or changes in the perception of stimulation might indicate a lead break). 3. At each office visit, including those scheduled due to changes reported by patient for items 1 or 2 above, interrogate the device and run device system diagnostics . If diagnostics suggest that a lead fracture is present, program the VNS generator to 0mA Please ensure this notice is communicated to all personnel within your organization who need to be aware of it. This action is being reported to the Food and Drug Administration. For questions customers can contact the recalling firm at: +1 (281) 228-7330 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at [email protected].
Quantity in commerce: 10
Distribution: US: NE, MO, AR, WV, KS, MA, IN
Product codes and lots: UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0532-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0532-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28

Product code LYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)