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Recall Observatory FDA recall evidence

Device product

EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

Z-0879-2021

November 13, 2020

Class I

Product summary

Firm
Boston Scientific Corporation
Event
Event 87014
Status
Terminated
Classification
Class I
Quantity
47000 units
Official record key
device-enforcement:Z-0879-2021

Official wording

Reason: There is potential for fractures which results in the inability to delivery therapy.

Code information: All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.

Distribution pattern: Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is potential for fractures which results in the inability to delivery therapy.