Class 2 Device Recall PerenniaDURA VNS Therapy Leads

• Date Initiated by Firm: December 02, 2021
• Create Date: January 28, 2022
• Recall Status: Terminated on January 25, 2024
• Recall Number: Z-0532-2022
• Recall Event ID: 89335
• PMA Number: P970003
• Product Classification: Stimulator, autonomic nerve, implanted for epilepsy or depression - Product Code LYJ
• 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)
• Code Information: UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458
• Recalling Firm/ Manufacturer: LivaNova USA, Inc.; 100 Cyberonics Blvd; Houston TX 77058-2069
• For Additional Information Contact: 281-228-7200
• Manufacturer 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.
• FDA Determined 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 in Commerce: 10
• Distribution: US: NE, MO, AR, WV, KS, MA, IN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.