medical Class I Updated 2021-01-27

Boston Scientific Corporation recalls EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component o

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
Lot/Code Info: All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.
View official government recall

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