LivaNova USA, Inc. recalls SenTiva

Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

On 12/12/2024, correction notices were mailed to customers asking them to do the following: 1. Monitor patient frequently and perform an on-demand System Diagnostic test at each visit per labeling (typical patient visit cadence is every 3-12 months). See VNS Therapy Physician's Manual, found in the Manuals Section https://www.livanova.com/epilepsy-vnstherapy/en-us/hcp/product-manuals or https://www.livanova.com/depression/en-us/healthcare-provider-resources. 2. Counsel prospective and current patients to ensure that they are aware of and understand the risks. You may elect to provide the patient letter. 3. Contact Customer Quality at 1-866-882-8804 or e-mail at cservices@livanova.com if communication with the generator using the Programming System indicates that: i. Diagnostic tests cannot be performed (Error Code 254 - Test Interrupted error message) ii. System Diagnostic test displays a LOW lead impedance result. 4. Encourage patients to: i. Notify you if there is a change in perceived clinical symptoms (e.g. increase in seizures or depressive symptoms, etc.). ii. Notify you if they no longer perceive any form of stimulation. 5. Ensure that this notice is communicated to all personnel within your organization who need to be aware. 6. Complete and return the response form via email to M1000FieldAction@livanova.com Firm is updating the VNS Therapy Instructions for Use (IFU) to reflect the patient management recommendations relevant to this issue. For questions contact the firm's Customer Quality at 1-866-882-8804 or e-mail cservices@livanova.com On 6/16/2025, updated recall notices were delivered in person notifying customers that devices with a design change were available so affected generators remaining in inventory should be replaced. New devices with the design change have serial numbers greater than 500,000. There are no new actions for devices that have already been implanted.

• FDA enforcement recordOfficial FDA database entry for Z-1072-2025
• FDA device classification · LYJOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find LivaNova USA, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.