LivaNova USA Inc recalls VNS Therapy¿ AspireSR¿ Generator

Recalled November 25, 2020 · FDA recall Z-0462-2021 · LivaNova USA

Hazard

Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4. · FDA Class II

Units

134 generators

Sold at

U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru

Description

Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.

Product

VNS Therapy¿ AspireSR¿ Generator

Manufacturer(s)

LivaNova USA Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →