Emblem S-ICD Pulse Generator and Emblem MRI S-ICD Pulse Generator
Brand(s)
Last updated
Summary
Product
Emblem S-ICD Pulse Generator and Emblem MRI S-ICD Pulse Generator
Issue
Medical devices - Performance
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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