medical Class II Updated 2023-08-30

Boston Scientific Corporation recalls EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Im

Recalled Product

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator


Hazard / Issue

There is a 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.

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE
View official government recall

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