FDA Medical Device Recalls (openFDA)
LivaNova USA, Inc.: 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)
- Recall number
- Z-0532-2022
- 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)
- Status
- Terminated
- Initiated
- 2021-12-02
- Posted
- not on file
- Terminated
- 2024-01-25
- 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.
- 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 cservices@LivaNova.com.
- Quantity
- 10
- Distribution
- US: NE, MO, AR, WV, KS, MA, IN
- Lot, serial or model codes
- UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458
- 510(k) numbers
- not on file
- PMA numbers
- ["P970003"]
- Product code
- LYJ
- Firm FEI
- 1000117004
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28