medical Class II Updated 2025-02-12

LivaNova USA, Inc. recalls SenTiva, REF: 1000C, Generators Part of the VNS Therapy Syst

Recalled Product

SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT, AR, DE

Lot/Code Info: UDI-DI: 05425025750405. All Serial Numbers less than 500,000.

View official government recall

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