LivaNova USA, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1072-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).

Product Classification:

Class II

Date Initiated: December 12, 2024

Date Posted: February 12, 2025

Recall Number: Z-1072-2025

Event ID: 95435

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.

Status: Ongoing

Product Quantity: 81,606

Code Information:

REF/UDI-DI: 1000/05425025750405, 1000-D/05425025750528 All Serial Numbers less than 500,000

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.

Voluntary or Mandated:

Voluntary: Firm initiated