LivaNova USA Inc recalls VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

Recall date

February 4, 2020

Source

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

Recall number

Z-1563-2020

FDA classification

Class II

Brand / firm

LivaNova USA Inc

Sold / distributed

U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT. Canada, and Israel.

Why it was recalled

False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.