FDA-Device2021-01-27Class I
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Boston Scientific Corporation
Hazard
There is potential for fractures which results in the inability to delivery therapy.
Sold states
Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
Affected count
47000 units
Manufactured in
4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, United States
Products
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0879-2021Don't want to check this manually?
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