Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter Recalled by Boston Scientific Corporation Due to There is potential for fractures which results in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Quantity: 47000 units
Why Was This Recalled?
There is potential for fractures which results in the inability to delivery therapy.
Where Was This Sold?
Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report