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Boston Scientific Corporation recalls EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Recalled November 9, 2022 · FDA recall Z-0152-2023 · Boston Scientific
Hazard
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. · FDA Class II
Units
142 devices
Sold at
Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.
Description
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Product
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →