medical Class II Updated 2019-09-25

Boston Scientific Corporation recalls Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

Recalled Product

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

Hazard / Issue

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Model A209, Serial Number (Use Before Date) - 213729 (7/24/2019), 213859 (7/26/2019), 213891 (7/27/2019), 213896 (7/27/2019), 213898 (7/27/2019), 213901 (7/27/2019), 213902 (7/27/2019), 213904 (7/27/2019), 213910 (7/27/2019), 213919 (7/27/2019), 213921 (7/27/2019), 213937 (7/27/2019), 213938 (7/27/2019), 213943 (7/27/2019), 213946 (7/27/2019), 213961 (7/28/2019), 213972 (7/28/2019), 213975 (7/28/2019), 213976 (7/28/2019), 213979 (7/28/2019), 213982 (7/28/2019), 213983 (7/28/2019), 214020 (7/31/2019), 214030 (7/31/2019), 214032 (7/31/2019), 214036 (7/31/2019), 214042 (7/31/2019), 214083 (7/31/2019);

View official government recall

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