Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Pro

FDA device recall Z-1067-2025 · posted 2025-01-30 · Open, Classified

Recall details

Recalling firm

LivaNova USA, Inc.

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

LYJ

Quantity affected

8223 units

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR,PA, PN, SC, SD, TN, TX,

Date initiated

2025-01-03

Date posted

2025-01-30

Location

Houston, TX