Company: LivaNova USA Inc
Date of Enforcement Report: 11/25/2020
Class II
PRODUCT
VNS Therapy AspireSR Generator
Recall Number: Z-0462-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
LivaNova USA Inc on 9/28/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
134 generators
DISTRIBUTION
U.S. Nationwide and International