Emblem S-icd Pulse Generator And Emblem Mri S-icd Pulse Generator

LivaNova is recalling the Emblem S-ICD and Emblem MRI S-ICD pulse generators (implantable heart devices) across Canada due to a performance issue. These devices are used to treat patients at risk of sudden cardiac death by detecting and treating dangerous heart rhythms. The recall affects all patients who have received these implants.

Product
Emblem S-ICD Pulse Generator and Emblem MRI S-ICD Pulse Generator
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-10-17
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3b13790e-ba18-41c3-8002-3f3c0be4dbf8