Recall – Implantable pulse generator trace may flatline

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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