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Recall Observatory FDA recall evidence

Device product

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

Z-2442-2023

July 11, 2023

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 92760
Status
Ongoing
Classification
Class II
Quantity
41,411 units
Official record key
device-enforcement:Z-2442-2023

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: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; 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.