Company: Boston Scientific Corporation
Date of Enforcement Report: 11/11/2020
Class II
PRODUCT
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Recall Number: Z-0319-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation on 9/22/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8 devices
DISTRIBUTION
U.S. Nationwide