Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Reported: September 25, 2019 Initiated: August 21, 2019 #Z-2542-2019
Product Description
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Reason for Recall
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 28 devices
- Distribution
- 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.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator. Recalled by Boston Scientific Corporation. Units affected: 28 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2019. Severity: Moderate. Recall number: Z-2542-2019.
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