Recall – Inadvertent modification of serial number renders VNS therapy programmer incompatible

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

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