Health product recall

Emblem S-Icd and Latitude Programming Systems

Last updated

Summary

Product
Emblem S-Icd and Latitude Programming Systems
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Emblem S-Icd System Not applicable. 3200
Latitude Programming System Not applicable. 3300

Issue

In December 2020, Boston Scientific committed to developing a software enhancement that detects and alerts Healthcare Professionals (HCPs) if an Emblem S-Icd exhibits hydrogen-induced accelerated battery depletion. This enhanced software allows clinicians to identify Emblem S-Icds exhibiting hydrogen-induced accelerated battery depletion sooner. This enhanced software is now available, and sales professionals are upgrading the programmers.

Recall start date: July 7, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Boston Scientific Corporation

4100 Hamline Avenue North, St. Paul, Minnesota, United States, 55112-5798

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64393