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Boston Scientific Corporation recalls EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Recalled February 3, 2021 · FDA recall Z-0936-2021 · Boston Scientific
Hazard
Accelerated battery depletion may result in a need for device replacement earlier than expected. · FDA Class II
Units
11296 units
Sold at
worldwide
Description
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Product
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →