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Recall Observatory FDA recall evidence

Device product

EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

Z-2441-2023

July 11, 2023

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 92760
Status
Ongoing
Classification
Class II
Quantity
3,856 units
Official record key
device-enforcement:Z-2441-2023

Official wording

Reason: 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.

Code information: GTIN: 00802526544101, 00802526548406, 00802526575105, 00802526575112, 00802526575129, 00802526575136, 00802526575143, 00802526575167, 00802526575181, 00802526575204, 00802526575211, 00802526575228, 00802526599002; All EMBLEM S-ICDs enrolled in LATITUDE

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.