Z-1073-2025Class II

SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus...

Name: Z-1073-2025 SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus...
Creator: LivaNova USA, Inc.
Published: 2024-12-12
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2024-12-12 / Open, Classified / root cause: design

FDA source

LivaNova USA, Inc. began a recall of SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS) on 2024-12-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1073-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-12
Posted: 2025-01-31
Recalling firm: LivaNova USA, Inc.
Product: SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected] 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 [email protected] 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 [email protected] 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.
Quantity in commerce: 48
Distribution: US: 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, VA, VT, WA, WI, WV, UT. OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA.
Product codes and lots: UDI-DI: 05425025750405. All Serial Numbers less than 500,000.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1073-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1072-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-01-31
Z-1073-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-01-31

Product code LYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)