LivaNova USA Inc recalls VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

Recall date

November 16, 2018

Source

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

Recall number

Z-0663-2020

FDA classification

Class II

Brand / firm

LivaNova USA Inc

Sold / distributed

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

Why it was recalled

This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.

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 Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly