Boston Scientific Corporation recalls Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

Recall date

August 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2543-2019

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Nationwide distribution to Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, O…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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