LivaNova USA, Inc. Recall 95435
Description: SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
LivaNova USA, Inc. Recall 95435 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1072-2025 |
| Event ID | 95435 |
| Event Description | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS). |
| Product Type | Devices |
| 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. |
| Quantity | 72,280 |
| Recall 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. |
| Device Classification | 20250212 |
| Device Code Info | REF/UDI-DI: 1000/05425025750405, 1000-D/05425025750528 All Serial Numbers less than 500,000 |
| Center Classification Date | 20250131 |
| Recall Initiation Date | 20241212 |
| Recalling Firm | LivaNova USA, Inc. |
| Initial Notification | Letter |
| Similar To |