LivaNova USA Inc recalls VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy

Recall date

August 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0561-2020

FDA classification

Class I

Brand / firm

LivaNova USA Inc

Sold / distributed

U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR. OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT

Why it was recalled

Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy