Recall Z-1068-2025 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA, Inc.
Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable
| Date | Jan 30, 2025 (initiated Jan 3, 2025) |
| Status | Open, Classified |
| Reason | Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. |
| Root cause | Device Design |
| Action | On January 3, 2025, LivaNova issued a "Urgent Medical Device Removal" via Mail to affected consignees. LivaNova ask consignees to take the following actions: 1. Monitor the patient for changes in clinical symptoms or if the patient loses perception of stimulation (e.g., the typical cadence for patient visits range from every 3-12 months). 2. Perform system diagnostic testing at each patient office visit to monitor generator battery status. 3. Counsel patients to do the following: i. Notify you if there is a change in perceived clinical symptoms ii. Notify you if they no longer perceive a |
| Quantity | 84 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of 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 and the countries of AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.