FDA-Device2023-08-30Class II
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Boston Scientific Corporation
Hazard
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Sold states
Worldwide
Affected count
3,856 units
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2441-2023Don't want to check this manually?
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