Recall Z-1072-2025 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
| Date | Jan 31, 2025 (initiated Dec 12, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 pa |
| Quantity | 81,606 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.