FDA-Device2019-09-25Class II
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Boston Scientific Corporation
Hazard
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.
Sold states
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, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin, Wyoming. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, , Lithuania, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. - Virgin Islands, United Arab Emirates, United Kingdom.
Affected count
404 devices
Manufactured in
4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, United States
Products
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2019Don't want to check this manually?
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