FDA-Device2021-02-17Class I
EMBLEM MRI S-ICD Model A219
Boston Scientific Corporation
Hazard
Electrical overstress may lead to device malfunction.
Sold states
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
Affected count
872 units
Manufactured in
4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, United States
Products
EMBLEM MRI S-ICD Model A219
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0951-2021Don't want to check this manually?
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