FDA-Device2021-02-03Class II
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Hazard
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Sold states
worldwide
Affected count
7093 units
Manufactured in
4100 Hamline Ave N Bldg 3, Saint Paul, MN, United States
Products
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0935-2021More Boston Scientific Corporation recalls
- FDA-Device2026-07-22Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
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