Z-0319-2021 Class II Terminated

Recalled by Boston Scientific Corporation — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
November 11, 2020
Initiation Date
September 22, 2020
Termination Date
September 4, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 devices

Product Description

Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application

Reason for Recall

There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.

Distribution Pattern

Distributed in US - AR, FL, IL, and TX

Code Information

Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751