FDA Medical devices recall ·
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with… recall
- Recall number
- Z-1073-2025
- Date
- (initiated December 12, 2024)
- Company / brand
- LivaNova USA, Inc.
100 Cyberonics Blvd, Houston, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 48
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 05425025750405. All Serial Numbers less than 500,000.
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.
States: Alaska Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1073-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.