FDA-Device2021-02-03Class II
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Boston Scientific Corporation
Hazard
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Sold states
worldwide
Affected count
7093 units
Manufactured in
4100 Hamline Ave N Bldg 3, Saint Paul, MN, United States
Products
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0935-2021Don't want to check this manually?
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