LivaNova USA, Inc. 2025-02-12 Health serious FDA
Health · FDA · Recall #FDA-Z-1072-2025
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. … Recall
Issued February 12, 2025 · LivaNova USA, Inc.
In February 2025, LivaNova USA, Inc. recalled the SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact LivaNova USA, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- LivaNova USA, Inc.
- Category
- Health
- Recall date
- February 12, 2025
- Units affected
- Not reported
- Sold at
- 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,
- Recall number
- FDA-Z-1072-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- LivaNova USA, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.