Skip to content

SenTiva, REF: 1000 recallZ-1072-2025 · LivaNova USA, Inc. · initiated Dec 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from LivaNova USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1072-2025
Status
Open, Classified
Initiated by the company
Dec 12, 2024
Posted by the FDA
Jan 31, 2025
Recalling firm
LivaNova USA, Inc.
Quantity
81,606
Product code
LYJ
FDA submissions
P970003
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 description

SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).

Code information (models, lots, serial numbers)

REF/UDI-DI: 1000/05425025750405, 1000-D/05425025750528 All Serial Numbers less than 500,000

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

21 devices cleared under P970003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95435).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page