medical Class II Updated 2023-08-30

Boston Scientific Corporation recalls EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implan

Recalled Product

EMBLEM S-ICD Pulse Generator Model A209; 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: 00802526544101, 00802526548406, 00802526575105, 00802526575112, 00802526575129, 00802526575136, 00802526575143, 00802526575167, 00802526575181, 00802526575204, 00802526575211, 00802526575228, 00802526599002; All EMBLEM S-ICDs enrolled in LATITUDE
View official government recall

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