LivaNova USA, Inc.: Device Recall
Recall #Z-1072-2025 · 12/12/2024
Recall Details
- Recall Number
- Z-1072-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- LivaNova USA, Inc.
- Status
- Ongoing
- Date Initiated
- 12/12/2024
- Location
- Houston, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81,606
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.
Product Description
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Distribution Pattern
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.
Other Recalls by LivaNova USA, Inc.
- Class II: Risk 01/03/2025
- Class II: Risk 01/03/2025
- Class II: Risk 12/12/2024