Health product recall

Emblem S-ICD Pulse Generator and Emblem MRI S-ICD Pulse Generator

Last updated

Summary

Product
Emblem S-ICD Pulse Generator and Emblem MRI S-ICD Pulse Generator
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 catalogue number

Emblem S-Icd Pulse Generator

00802526548406
00802526575167
00802526599002
00802526544101
00802526575228
00802526575105
00802526575136
00802526575143
00802526575112
00802526575211
00802526575129
00802526575181
00802526575204

A209

Emblem Mri S-Icd Pg

00802526584404
00802526590405
00802526590436
00802526581519
00802526584411
00802526590429

A219

Issue

Boston Scientific Corporation (BSC) is initiating a product advisory notification for the Emblem S-ICD pulse generator and Emblem MRI S-ICD pg to inform customers that a software update for the Emblem S-ICD is available to correct the potential for a rare interaction between the Emblem S-ICD and latitude communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

Recall start date: October 2, 2023

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-74433

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