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

Recalled January 27, 2021 · FDA recall Z-0879-2021 · Boston Scientific

Hazard

There is potential for fractures which results in the inability to delivery therapy. · FDA Class I

Units

47000 units

Sold at

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

Description

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

Product

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

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →