SenTiva VNS Therapy (LivaNova) – Therapy Interruption (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

Recommended Action

Per FDA guidance

On January 3, 2025, LivaNova issued a "Urgent Medical Device Removal" via Mail to affected consignees. LivaNova ask consignees to take the following actions: 1. Monitor the patient for changes in clinical symptoms or if the patient loses perception of stimulation (e.g., the typical cadence for patient visits range from every 3-12 months). 2. Perform system diagnostic testing at each patient office visit to monitor generator battery status. 3. Counsel patients to do the following: i. Notify you if there is a change in perceived clinical symptoms ii. Notify you if they no longer perceive any form of stimulation. iii. Patients with epilepsy who have Magnet Mode enabled should be reminded to use the patient magnet daily to check for the sensation of stimulation to confirm proper generator function, in alignment with recommendations in product labeling for all VNS generator models. Notification Acknowledgement Follow one of the options below to acknowledge receipt of this notification: Option 1 1. Using the QR Code or website address and access code on page 1 of this letter, access your customer page via our secure customer portal ( TRIEVR ) to provide the required information to LivaNova USA, Inc. via a secure, transmission-encrypted system. 2. Answer the question in the Response section indicating your receipt and acknowledgement of the notification. 3. Submit the response by selecting the Send Response button at the bottom of the page.